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LINK Instruments - Alignment and positioning instruments

FDA UDI

Class I (US FDA UDI)

by WALDEMAR LINK GmbH & Co. KG

Identity

Trade Name
LINK Instruments - Alignment and positioning instruments FDA UDI
Generic Name
Surgical saw blade, oscillating, single-use FDA UDI
Device Name
Suturing needle holder, reusable - Gemini SL Total Knee System FDA UDI
Model / Reference
317-664 FDA UDI
Description
Suturing needle holder, reusable - Gemini SL Total Knee System FDA UDI

Identifiers

Primary DI / UDI-DI
04026575318100 FDA UDI
FDA Product Code
FZX FDA UDI
GMDN Term
Surgical saw blade, oscillating, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 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

Yes

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: Surgical saw blade, oscillating, single-use

LINK Instruments - Alignment and positioning instruments by WALDEMAR LINK GmbH & Co. KG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical saw blade, oscillating, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
WALDEMAR LINK GmbH & Co. KG

Sources (1)

  • FDA UDI c7a87caf-ef0a-405c-a279-533f12a7eb8e 33 fields · synced May 30, 2026