BiMobile Dual Mobility System Instrument

GUDID 04026575439355

Impaction Expander, full metal version, Ø 46 mm

WALDEMAR LINK GmbH & Co. KG

Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor
Primary Device ID04026575439355
NIH Device Record Keyb1e470a3-a68c-4c65-ac1c-5477fa71c71c
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiMobile Dual Mobility System Instrument
Version Model Number184-354/46
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
GS104026575439355 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04026575439355]

Moist Heat or Steam Sterilization


[04026575439355]

Moist Heat or Steam Sterilization


[04026575439355]

Moist Heat or Steam Sterilization


[04026575439355]

Moist Heat or Steam Sterilization


[04026575439355]

Moist Heat or Steam Sterilization


[04026575439355]

Moist Heat or Steam Sterilization


[04026575439355]

Moist Heat or Steam Sterilization


[04026575439355]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-29
Device Publish Date2022-06-21

On-Brand Devices [BiMobile Dual Mobility System Instrument]

04026575439478Impaction Expander, full metal version, Ø 70 mm
04026575439461Impaction Expander, full metal version, Ø 68 mm
04026575439454Impaction Expander, full metal version, Ø 66 mm
04026575439447Impaction Expander, full metal version, Ø 64 mm
04026575439430Impaction Expander, full metal version, Ø 62 mm
04026575439423Impaction Expander, full metal version, Ø 60 mm
04026575439416Impaction Expander, full metal version, Ø 58 mm
04026575439409Impaction Expander, full metal version, Ø 56 mm
04026575439393Impaction Expander, full metal version, Ø 54 mm
04026575439386Impaction Expander, full metal version, Ø 52 mm
04026575439379Impaction Expander, full metal version, Ø 50 mm
04026575439362Impaction Expander, full metal version, Ø 48 mm
04026575439355Impaction Expander, full metal version, Ø 46 mm
04026575439348Impaction Expander, full metal version, Ø 44 mm
04026575439331Impaction Expander, full metal version, Ø 42 mm
04026575439324Impactor Handle
04026575439317Alignment Guide

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