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Manufacturers
Integra LifeSciences Corp. d.b.a. Integra Pain Management
Manufacturer Address
Integra LifeSciences Corp. d.b.a. Integra Pain Management, 3498 W 2400 S Ste 1050, Salt Lake City UT 84119-1135
Manufacturer Parent Company (2017)
Integra LifeSciences Holdings Corporation
Source
USFDA
3 Events
Recall of INTEGRA Spinal Tray
Recall of Device Recall PHS Spinal Tray 24G Gertie Marx
Recall of Device Recall Integra Cranial Access Kits
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3 devices in the database
INTEGRA Spinal Tray
Model / Serial
The affected lots of Integra¿ Spinal Trays were manufactured on 2/11/205 and on 7/11/2015. Lots: W1503004; S1501531; S1505556;
Product Classification
Anesthesiology Devices
Device Class
2
Implanted device?
No
Distribution
US Distribution to the states of : OH and CA. No foreign, Govt/VA/military consignee.
Product Description
INTEGRA Spinal Tray, Catalogue No: 3404875, Contents: 10 Each per Case, Sterile.
Device Recall PHS Spinal Tray 24G Gertie Marx
Model / Serial
Lot Number affected: W1503532
Product Classification
Anesthesiology Devices
Device Class
2
Implanted device?
No
Distribution
Distributed to CA.
Product Description
PHS Spinal Tray 24G Gertie Marx, Catalogue No. 899379. || Intended to provide licensed medical professionals with a kit containing drugs and other medical devices that are used to support the administration of general, local anesthetics.
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
One manufacturer with a similar name
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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
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