LINK Instrument 445-009/00

GUDID 04026575182503

Instrument Set

WALDEMAR LINK GmbH & Co. KG

Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable
Primary Device ID04026575182503
NIH Device Record Key620383c2-cb3f-4e70-b310-b9c83f409b7d
Commercial Distribution StatusIn Commercial Distribution
Brand NameLINK Instrument
Version Model Number445-009/00
Catalog Number445-009/00
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
GS104026575182503 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04026575182503]

Moist Heat or Steam Sterilization


[04026575182503]

Moist Heat or Steam Sterilization


[04026575182503]

Moist Heat or Steam Sterilization


[04026575182503]

Moist Heat or Steam Sterilization


[04026575182503]

Moist Heat or Steam Sterilization


[04026575182503]

Moist Heat or Steam Sterilization


[04026575182503]

Moist Heat or Steam Sterilization


[04026575182503]

Moist Heat or Steam Sterilization


[04026575182503]

Moist Heat or Steam Sterilization


[04026575182503]

Moist Heat or Steam Sterilization


[04026575182503]

Moist Heat or Steam Sterilization


[04026575182503]

Moist Heat or Steam Sterilization


[04026575182503]

Moist Heat or Steam Sterilization


[04026575182503]

Moist Heat or Steam Sterilization


[04026575182503]

Moist Heat or Steam Sterilization


[04026575182503]

Moist Heat or Steam Sterilization


[04026575182503]

Moist Heat or Steam Sterilization


[04026575182503]

Moist Heat or Steam Sterilization


[04026575182503]

Moist Heat or Steam Sterilization


[04026575182503]

Moist Heat or Steam Sterilization


[04026575182503]

Moist Heat or Steam Sterilization


[04026575182503]

Moist Heat or Steam Sterilization


[04026575182503]

Moist Heat or Steam Sterilization


[04026575182503]

Moist Heat or Steam Sterilization


[04026575182503]

Moist Heat or Steam Sterilization


[04026575182503]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2021-07-08
Device Publish Date2019-07-24

On-Brand Devices [LINK Instrument]

04026575185924Impactor
04026575259434Screw
04026575259427Screw
04026575259106Trial Neck
04026575259090Trial Neck
04026575258024Screw
04026575182190Trial Stem
04026575182183Trial Stem
04026575182176Trial Stem
04026575182169Trial Stem
04026575182152Trial Stem
04026575182145Trial Stem
04026575182138Trial Stem
04026575182121Trial Stem
04026575182114Trial Stem
04026575182107Trial Stem
04026575182091Trial Stem
04026575182084Trial Stem
04026575181964Trial Neck
04026575181957Trial Neck
04026575181940Trial Neck
04026575181933Trial Neck
04026575437412Trial Plateau
04026575437405Spacer
04026575437399Spacer
04026575437382Spacer
04026575437375Spacer
04026575437368Distal Cutting Block
04026575434282Femoral Trial Box
04026575434275Femoral Trial Box
04026575434268Femoral Trial Box
04026575434251Femoral Trial Box
04026575434244Femoral Trial Box
04026575434237Femoral Trial Box
04026575434220Femoral Trial Box
04026575434213Femoral Trial Box
04026575432318Femoral Sizer
04026575429387Cutting Block
04026575429370Cutting Block
04026575429363Cutting Block
04026575420278Cutting Block
04026575420261Cutting Block
04026575420254Cutting Block
04026575420247Tibial Base Guide
04026575420216Cutting Block
04026575420209Cutting Block
04026575420193Cutting Block
04026575420186Cutting Block
04026575420179Cutting Block
04026575420162Cutting Block

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