Gamma

FDA UDI

Class II (US FDA UDI)

by Stryker Corp.

Identity

Trade Name: GAMMA FDA UDI
Generic Name: Surgical drill guide, reusable FDA UDI
Device Name: Speedlock Sleeve FDA UDI
Model / Reference: 1320-1120 FDA UDI
Description: Speedlock Sleeve FDA UDI

Identifiers

Catalog Number: 1320-1120 FDA UDI
Primary DI / UDI-DI: 07613154893669 FDA UDI
FDA Product Code: HSB FDA UDI
GMDN Term: Surgical drill guide, 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical drill guide, reusable

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

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Stryker Corp.

Sources (1)

FDA UDI 6429d9dc-1a7d-467e-b85a-ec41fb5f4e09 34 fields · synced May 31, 2026