LINK Instruments - Drills, reamers and saw blades

FDA UDI

Class I (US FDA UDI)

by WALDEMAR LINK GmbH & Co. KG

Identity

Trade Name: LINK Instruments - Drills, reamers and saw blades FDA UDI
Generic Name: Fluted surgical drill bit, reusable FDA UDI
Device Name: Fluted surgical drill bit, reusable - Gemini SL Total Knee System FDA UDI
Model / Reference: 317-649/08E FDA UDI
Description: Fluted surgical drill bit, reusable - Gemini SL Total Knee System FDA UDI

Identifiers

Primary DI / UDI-DI: 04026575366118 FDA UDI
FDA Product Code: HTW FDA UDI
GMDN Term: Fluted surgical drill bit, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Fluted surgical drill bit, reusable

LINK Instruments - Drills, reamers and saw blades by WALDEMAR LINK GmbH & Co. KG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Revision Knee System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class I
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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 I	Pending data

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Manufacturer

Manufacturer: WALDEMAR LINK GmbH & Co. KG

Sources (1)

FDA UDI 526eff9c-e5f6-4ea4-af06-a73ecacb7f1a 33 fields · synced Jun 8, 2026