LINK Instruments - Impactors, extractors and insertion

GUDID 04026575414260

Orthopaedic prosthesis implantation instrument, reusable - SPII Model Lubinus Hip Stem

WALDEMAR LINK GmbH & Co. KG

Orthopaedic prosthesis implantation positioning instrument, reusable

Primary Device ID	04026575414260
NIH Device Record Key	e8cd790b-063f-4ffb-9b38-931ac4539b9e
Commercial Distribution Status	In Commercial Distribution
Brand Name	LINK Instruments - Impactors, extractors and insertion
Version Model Number	130-610/01
Company DUNS	315675488
Company Name	WALDEMAR LINK GmbH & Co. KG
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04026575414260 [Primary]

FDA Product Code

IMPACTOR

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[04026575414260]

Moist Heat or Steam Sterilization

[04026575414260]

Moist Heat or Steam Sterilization

[04026575414260]

Moist Heat or Steam Sterilization

[04026575414260]

Moist Heat or Steam Sterilization

[04026575414260]

Moist Heat or Steam Sterilization

[04026575414260]

Moist Heat or Steam Sterilization

[04026575414260]

Moist Heat or Steam Sterilization

[04026575414260]

Moist Heat or Steam Sterilization

[04026575414260]

Moist Heat or Steam Sterilization

[04026575414260]

Moist Heat or Steam Sterilization

[04026575414260]

Moist Heat or Steam Sterilization

[04026575414260]

Moist Heat or Steam Sterilization

[04026575414260]

Moist Heat or Steam Sterilization

[04026575414260]

Moist Heat or Steam Sterilization

[04026575414260]

Moist Heat or Steam Sterilization

[04026575414260]

Moist Heat or Steam Sterilization

[04026575414260]

Moist Heat or Steam Sterilization

[04026575414260]

Moist Heat or Steam Sterilization

[04026575414260]

Moist Heat or Steam Sterilization

[04026575414260]

Moist Heat or Steam Sterilization

[04026575414260]

Moist Heat or Steam Sterilization

[04026575414260]

Moist Heat or Steam Sterilization

[04026575414260]

Moist Heat or Steam Sterilization

[04026575414260]

Moist Heat or Steam Sterilization

[04026575414260]

Moist Heat or Steam Sterilization

[04026575414260]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2023-05-03
Device Publish Date	2022-12-19

On-Brand Devices [LINK Instruments - Impactors, extractors and insertion]

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04026575414260	Orthopaedic prosthesis implantation instrument, reusable - SPII Model Lubinus Hip Stem
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04026575397013	Orthopaedic implant inserter/extractor, reusable - Megasystem-C Tumor- and Revision System
04026575382675	Orthopaedic implant inserter/extractor, reusable - Gemini SL Total Knee System
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04026575382651	Orthopaedic implant inserter/extractor, reusable - Gemini SL Total Knee System
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04026575318087	Orthopaedic implant inserter/extractor, reusable - Gemini SL Total Knee System
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04026575087891	Orthopaedic implant inserter/extractor, reusable - Gemini SL Total Knee System
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04026575060641	Orthopaedic prosthesis instrument, reusable - General Instrument
04026575047895	Orthopaedic prosthesis instrument, reusable - General Instrument
04026575044221	Orthopaedic implant inserter/extractor, reusable - LINK SLED Prosthesis
04026575037193	Orthopaedic prosthesis instrument, reusable - General Instrument
04026575037186	Orthopaedic prosthesis instrument, reusable - General Instrument
04026575033249	Orthopaedic prosthesis instrument, reusable - General Instrument
04026575033232	Orthopaedic prosthesis instrument, reusable - General Instrument
04026575033225	Orthopaedic prosthesis instrument, reusable - General Instrument
04026575032945	Orthopaedic implant inserter/extractor, reusable - General Instrument
04026575416004	Surgical mallet - SPII Model Lubinus Hip Stem
04026575390489	Surgical mallet - General Instrument
04026575214679	Surgical instrument handle, non-torque-limiting - Vario-Cup System

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