Devices

Integra Cranial Access Kit

  • Model / Serial
    INSHITH Lots: W1205183,,W1207036,,W1209165,,W1209166,,W1209168,,W1210156,,W1210157,,W1210158,,W1210159,,W1210160,,W1211021,,W1211030,,W1211135,,W1211136,,W1211137,,W1212170 INSHITHND Lots: W1210230 INSHITHRZN Lots: W1209156,,W1211182,,W1212090,,W1212125,,W1212178,,W1301258,,W1302005,,W1302031,,W1303148
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including CA, CO, FL, IN, KS, NC, NV, NY, OK, TN, TX, VA, WA, and WI.
  • Product Description
    Cranial Access (CRAK) Kits, Product / Catalogue No.s: INSHITH, INSHITHND, INSHITHRZN || The kits allow for access to the subarachnoid space or the lateral ventricles of the brain. The kits are intended to be used with an external drainage and monitoring system in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF, and to monitor ICP.
  • Manufacturer
    Integra LifeSciences Corp. d.b.a. Integra Pain Management
  • 1 Event

Manufacturer

Integra LifeSciences Corp. d.b.a. Integra Pain Management
  • Manufacturer Address
    Integra LifeSciences Corp. d.b.a. Integra Pain Management, 3498 West 2400 South #1050, Salt Lake City UT 84119
  • Manufacturer Parent Company (2017)
    Integra LifeSciences Holdings Corporation
  • Source
    USFDA

2 devices with a similar name

Learn more about the data here

Device Recall Integra Cranial Access Kits
  • Model / Serial
    Lot W1605101: Exp 2016-12 Lot W1605103: Exp 2016-11 Lot W1605106: Exp 2016-11 Lot W1606063: Exp 2016-12 Lot W1605101: Exp 2016-12 W1605103: 2016-11 W1605106: 2016-11 W1606063: 2016-12
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and VA/govt/military. No foreign consignees.
  • Product Description
    Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND
  • Manufacturer
    Integra LifeSciences Corp. d.b.a. Integra Pain Management
Device Recall Integra Cranial Access Kit
  • Model / Serial
    Lot No. W1302120 Expires 2/1/2014  Lot No. W1305038 Expires 8/1/2015  Lot No. W1306137 Expires 9/1/2014
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution
  • Product Description
    Integra Cranial Access Kit, Model Number HITHSP10, Rx Only. || Integra Cranial Access Kits (CRAK) allows for burr hole access to the subarachnoid space or the lateral ventricles of the brain. The kit is intended to be used with an external drainage and monitoring system in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of Cerebrospinal Fluid (CSF), and to monitor ICP. These kits contain all components and accessories required for burr hole access into the cranium.
  • Manufacturer
    Integra LifeSciences Corp. d.b.a. Integra Pain Management