LINK Instruments - Saw and drill guides

GUDID 04026575397556

Orthopaedic implant aiming/guiding block, reusable - Megasystem-C Tumor- and Revision System

WALDEMAR LINK GmbH & Co. KG

Orthopaedic implant aiming/guiding block, reusable
Primary Device ID04026575397556
NIH Device Record Key2de0616a-f919-4f99-a8c6-e03d5594f1ba
Commercial Distribution StatusIn Commercial Distribution
Brand NameLINK Instruments - Saw and drill guides
Version Model Number16-3228/04
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
GS104026575397556 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04026575397556]

Moist Heat or Steam Sterilization

[04026575397556]

Moist Heat or Steam Sterilization

[04026575397556]

Moist Heat or Steam Sterilization

[04026575397556]

Moist Heat or Steam Sterilization

[04026575397556]

Moist Heat or Steam Sterilization

[04026575397556]

Moist Heat or Steam Sterilization

[04026575397556]

Moist Heat or Steam Sterilization

[04026575397556]

Moist Heat or Steam Sterilization

[04026575397556]

Moist Heat or Steam Sterilization

[04026575397556]

Moist Heat or Steam Sterilization

[04026575397556]

Moist Heat or Steam Sterilization

[04026575397556]

Moist Heat or Steam Sterilization

[04026575397556]

Moist Heat or Steam Sterilization

[04026575397556]

Moist Heat or Steam Sterilization

[04026575397556]

Moist Heat or Steam Sterilization

[04026575397556]

Moist Heat or Steam Sterilization

[04026575397556]

Moist Heat or Steam Sterilization

[04026575397556]

Moist Heat or Steam Sterilization

[04026575397556]

Moist Heat or Steam Sterilization

[04026575397556]

Moist Heat or Steam Sterilization

[04026575397556]

Moist Heat or Steam Sterilization

[04026575397556]

Moist Heat or Steam Sterilization

[04026575397556]

Moist Heat or Steam Sterilization

[04026575397556]

Moist Heat or Steam Sterilization

[04026575397556]

Moist Heat or Steam Sterilization

[04026575397556]

Moist Heat or Steam Sterilization

[04026575397556]

Moist Heat or Steam Sterilization

[04026575397556]

Moist Heat or Steam Sterilization

[04026575397556]

Moist Heat or Steam Sterilization

[04026575397556]

Moist Heat or Steam Sterilization

[04026575397556]

Moist Heat or Steam Sterilization

[04026575397556]

Moist Heat or Steam Sterilization

[04026575397556]

Moist Heat or Steam Sterilization

[04026575397556]

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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