MobileLink Acetabular Cup System - Instruments

GUDID 04026575192373

Orthopaedic implant impactor - MobileLink Acetabular Cup System

WALDEMAR LINK GmbH & Co. KG

Orthopaedic implant impactor, reusable
Primary Device ID04026575192373
NIH Device Record Key1f57d8c9-1d91-406a-b4c2-431c4474e231
Commercial Distribution StatusIn Commercial Distribution
Brand NameMobileLink Acetabular Cup System - Instruments
Version Model Number183-168/01
Company DUNS315675488
Company NameWALDEMAR LINK GmbH & Co. KG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104026575192373 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04026575192373]

Moist Heat or Steam Sterilization


[04026575192373]

Moist Heat or Steam Sterilization


[04026575192373]

Moist Heat or Steam Sterilization


[04026575192373]

Moist Heat or Steam Sterilization


[04026575192373]

Moist Heat or Steam Sterilization


[04026575192373]

Moist Heat or Steam Sterilization


[04026575192373]

Moist Heat or Steam Sterilization


[04026575192373]

Moist Heat or Steam Sterilization


[04026575192373]

Moist Heat or Steam Sterilization


[04026575192373]

Moist Heat or Steam Sterilization


[04026575192373]

Moist Heat or Steam Sterilization


[04026575192373]

Moist Heat or Steam Sterilization


[04026575192373]

Moist Heat or Steam Sterilization


[04026575192373]

Moist Heat or Steam Sterilization


[04026575192373]

Moist Heat or Steam Sterilization


[04026575192373]

Moist Heat or Steam Sterilization


[04026575192373]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-05
Device Publish Date2023-04-27

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04026575433377Surgical instrument handle, non-torque-limiting - MobileLink Acetabular Cup System
04026575274222Surgical implant handling forceps - MobileLink Acetabular Cup System
04026575208401Orthopaedic implant inserter/extractor, reusable - MobileLink Acetabular Cup System
04026575192373Orthopaedic implant impactor - MobileLink Acetabular Cup System
04026575224623Orthopaedic implant aiming/guiding block, reusable - General instrument

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