Endo-Model Saddle Prosthesis 15-8007/26

GUDID 04026575047840

Setscrews

WALDEMAR LINK GmbH & Co. KG

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID04026575047840
NIH Device Record Keyee930c6c-1667-4956-b6c0-0c8328784b3e
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndo-Model Saddle Prosthesis
Version Model Number15-8007/26
Catalog Number15-8007/26
Company DUNS315675488
Company NameWALDEMAR LINK GmbH & Co. KG
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104026575047840 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWLProsthesis, Hip, Hemi-, Femoral, Metal

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-02-19
Device Publish Date2015-11-01

On-Brand Devices [Endo-Model Saddle Prosthesis]

04026575047840Setscrews
04026575047765Fixation Screw

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