FDA.reportPublic FDA data

VARIAX

Primary DI
07613327129113
Brand
VARIAX
Company
Stryker GmbH
Model
990310
Catalog number
990310
Device description
Instrument Kit
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HRSPlate, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327129113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327129113076133271291137613327129113

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
481999654
Device count
1
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327625066PANGEA5421165421162024-12-01
00886385019741SR PIP17-13152017-06-27
00886385019758SR PIP17-13162017-06-27
00886385019765SR PIP17-13172017-06-27
00886385019772SR PIP17-13182017-06-27
00886385019789SR PIP17-13192017-06-27
00886385019796SR PIP17-13202017-06-27
00886385019802SR PIP17-13212017-06-27
00886385019819SR PIP17-13222017-06-27
00886385019826SR PIP17-13232017-06-27
00886385019833SR PIP17-13242017-06-27
00886385019840SR PIP17-13252017-06-27
00886385019857SR PIP17-13262017-06-27
00886385019864SR PIP17-13272017-06-27
00886385019871SR PIP17-13282017-06-27
00886385019888SR PIP17-13292017-06-27
00886385019895SR PIP17-13302017-06-27
00886385019901SR PIP17-13312017-06-27
00886385019918SR PIP17-13322017-06-27
00886385019925SR PIP17-13332017-06-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613154605453MATTAStryker GmbHHRS2025-09-16
07613154320288MATTAStryker GmbHHRS2023-10-20
07613154320332MATTAStryker GmbHHRS2023-10-20
07613154320349MATTAStryker GmbHHRS2023-10-20
07613154320356MATTAStryker GmbHHRS2023-10-20
07613154320363MATTAStryker GmbHHRS2023-10-20
07613154320370MATTAStryker GmbHHRS2023-10-20
07613154320387MATTAStryker GmbHHRS2023-10-20
07613154320394MATTAStryker GmbHHRS2023-10-20
07613154320400MATTAStryker GmbHHRS2023-10-20
07613154320417MATTAStryker GmbHHRS2023-10-20
07613154320455MATTAStryker GmbHHRS2023-10-20
07613154320479MATTAStryker GmbHHRS2023-10-20
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07613154320530MATTAStryker GmbHHRS2023-10-20
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07613154320622MATTAStryker GmbHHRS2023-10-20
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07613154320677MATTAStryker GmbHHRS2023-10-20
07613154320707MATTAStryker GmbHHRS2023-10-20
07613154320714MATTAStryker GmbHHRS2023-10-20
07613154320721MATTAStryker GmbHHRS2023-10-20
07613154320752MATTAStryker GmbHHRS2023-10-20
07613154320783MATTAStryker GmbHHRS2023-10-20
07613154320790MATTAStryker GmbHHRS2023-10-20
07613154320806MATTAStryker GmbHHRS2023-10-20
07613154320813MATTAStryker GmbHHRS2023-10-20
07613154320882MATTAStryker GmbHHRS2023-10-20
07613154320943MATTAStryker GmbHHRS2023-10-20