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Gamma

FDA UDI

Class II (US FDA UDI)

by Stryker Corp.

Identity

Trade Name
GAMMA FDA UDI
Generic Name
Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
Device Name
Instrument Set Gamma3 Distal Targeting R2.0 FDA UDI
Model / Reference
1320-5002 FDA UDI
Description
Instrument Set Gamma3 Distal Targeting R2.0 FDA UDI

Identifiers

Catalog Number
1320-5002 FDA UDI
Primary DI / UDI-DI
07613252232247 FDA UDI
FDA Product Code
HSB FDA UDI
GMDN Term
Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3020 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic surgical procedure kit, non-medicated, reusable

Gamma by Stryker Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic surgical procedure kit, non-medicated, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Stryker Corp.

Sources (1)

  • FDA UDI ccaf3d11-8d86-4699-9ae3-7302d4b6326c 34 fields · synced Jun 1, 2026