Devices

Integra

  • Model / Serial
    Putty Part Number 7700713001 510 K- K062353 Device Listing Number - E604163  Integra MOZAIKTM Putty 2.5cc Reference No. - PTY10125ITL Batch number - 105BR02l5949  Integra MOZAIKTM Putty 5cc Refernce No. - PTY10155ITL Batch No. - 105BR0216024  Integra MOZAIKTM Putty lOcc Reference No.- PTY10210ITL Batch No. - 105BR0215956
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution
  • Product Description
    Integra Mozaik Putty || 2.5cc, 5 cc, 10 cc || Product Usage: || The product is a bone graft substitute composed of collagen (Type 1) and ceramic (IP3-Tricalcium phosphate) matrix in putty and strip forms. The product is intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities, spine. and pelvis not intrinsic to the stability of the bony structure. Integra Mozaik is also indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone. Following placement in the bone void or a defect Integra Mozaik is reabsorbed and replaced with bone during the healing process.
  • Manufacturer
    Integra LifeSciences Corp.
  • 1 Event

Manufacturer

Integra LifeSciences Corp.

722 devices with a similar name

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Device Recall Integra XKnife Stereotactic Radiosurgery and Radiotherapy Treatment Planning
  • Model / Serial
    Software Versions 5.0.1 and 5.0.2.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the states of IL, ID, LA, MA, NJ, NY, OH, PA, and SD.
  • Product Description
    Integra XKnife¿ Stereotactic Radiosurgery and Radiotherapy Treatment Planning, || Software Versions 5.0.1 and 5.0.2. || Intended for use in stereotactic and non-stereotactic (frameless stereotactic), collimated beam, computer planned, linear accelerator (Linac) based treatment.
  • Manufacturer
    Integra LifeSciences Corp.
Arrow Super ArrowFlex® PSI Set with Integral Hemostasis Valve
Device Recall Integra CEM Nosecones
  • Model / Serial
    CEM Nosecone Catalogue No. C6623 Lot numbers: 1092855, 1093129, 1100436, 1100437, 1101217, 1101328, 1103393, 1104265, 1105067, 1110311, 1110892, 1112182, 1112183, 1114112, 1114655, 1115225, 1115499, 1115500,  1120771, 1121141, 1121142, 1121383, 1121627, 1122258, 1122259, 1123049 and 1130710.  CEM Nosecone, Catalogue No. C6636: 1091431, 1091679, 1091680, 1093475, 1095103, 1095416, 1095417, 1100242, 1100434, 1100435, 1101094, 1101218, 1101219, 1103104, 1103395, 1103849, 1103849, 1103850, 1103852, 1103917, 1103918, 1103922, 1104257, 1104263, 1105071, 1110475, 1110476, 1110978, 1111490, 1111493, 1112187, 1112188, 1112212, 1113179, 1113180, 1113663, 1114357, 1114358, 1114659, 1114660, 1115039, 1115502, 1115504, 1115505, 1120776, 1120777, 1121167, 1121168, 1121169, 1121565, 1121566, 1121567, 1122344, 1123051, 1123052, 1123508, 1123511 and 1124053.
  • Product Classification
    Neurological Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA and the countries of Austria, Australia, Bangladesh, Belgium, Bulgaria, Brazil, Switzerland, Canada, China, Costa Rica, Czech Republic, Germany, Dominican Republic, Egypt, Emirates, Spain, Finland, France, Great Britian, Hong Kong, Hungary, Indonesia, Ireland, Israel, India, Italy, Japan, Korea (South), Kuwait, Lebanon, Sri Lanka, Latvia, Macedonia, Mexico, Malaysia, Netherlands, Philippines, Pakistan, Poland, Portugal, Qatar, Serbia, Saudi Arabia, Singapore, Slovenia, Thailand, Tunisia, Taiwan, United Arab, Viet Nam and South Africa.
  • Product Description
    Integra CUSA excel. CEM Nosecone for CUSA EXcel System. || The CEM Nosecone is intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator. Used in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.
  • Manufacturer
    Integra LifeSciences Corp.
Device Recall Integra(R) Jarit(R) Monopolar Cable
  • Model / Serial
    Catalogue No. 600-290. All lots distributed since 2004.
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide including Canada.
  • Product Description
    Integra(R) Jarit(R) Monopolar Cable (Catalogue No. 600-290). || For use in endoscopic surgery. For use when a rigid endoscopic instrument for grasping and/or dissecting if soft tissue is determined to be appropriate by the surgeon. Monopolar electrosurgical current can be used for coagulation and/or cutting.
  • Manufacturer
    Integra LifeSciences Corp.
Device Recall VITROS 5600 Integrated System
  • Model / Serial
    Serial Numbers 56000118 through 56001583
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution- USA (nationwide) including Puerto Rico and countries of: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Republic of Panama, Singapore, Spain, and Venezuela.
  • Product Description
    VITROS 5600 Integrated System, Product Code 6802413. || Intended for use in the measurement of a variety of chemistry analytes.
  • Manufacturer
    Ortho-Clinical Diagnostics
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