LINK Instruments - Chisel, bone curette, raspatory, rongeur

FDA UDI

Class I (US FDA UDI)

by WALDEMAR LINK GmbH & Co. KG

Identity

Trade Name: LINK Instruments - Chisel, bone curette, raspatory, rongeur FDA UDI
Generic Name: Orthopaedic cement extractor, manual FDA UDI
Device Name: Orthopaedic prosthesis instrument, reusable - General Instrument FDA UDI
Model / Reference: 130-682 FDA UDI
Description: Orthopaedic prosthesis instrument, reusable - General Instrument FDA UDI

Identifiers

Primary DI / UDI-DI: 04026575033348 FDA UDI
FDA Product Code: HWB FDA UDI
GMDN Term: Orthopaedic cement extractor, manual 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: Orthopaedic cement extractor, manual

LINK Instruments - Chisel, bone curette, raspatory, rongeur by WALDEMAR LINK GmbH & Co. KG — Class I — FDA UDI — listed in FDA GUDID

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Also classified as Orthopaedic cement extractor, manual.

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Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
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Forceps - Rongeur for Cement Extraction (Slide measures 205mm) - 20mm Jaw Width — PLATTS & NISBETT LIMITED · Class I

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 d90250a2-10de-468a-b71f-2b1d5c369fed 33 fields · synced May 29, 2026