LINK Vario-Cup Prosthesis 107-220/57

GUDID 04026575329618

Vario-Head Cup,self-centering

WALDEMAR LINK GmbH & Co. KG

Bipolar femoral head outer component, hemiarthroplasty
Primary Device ID04026575329618
NIH Device Record Key17ac6035-7639-4b99-b810-832515653f78
Commercial Distribution StatusIn Commercial Distribution
Brand NameLINK Vario-Cup Prosthesis
Version Model Number107-220/57
Catalog Number107-220/57
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 Batchfalse
Serial Numbertrue
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
GS104026575329618 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-09-09
Device Publish Date2015-11-01

On-Brand Devices [LINK Vario-Cup Prosthesis]

04026575395897Safety Ring,for Head Ø 28 mm
04026575329748Vario-Head Cup,without safety ring
04026575329731Vario-Head Cup,without safety ring
04026575329724Vario-Head Cup,without safety ring
04026575329717Vario-Head Cup,without safety ring, not self-centering
04026575329700Vario-Head Cup,without safety ring, not self-centering
04026575329694Vario-Head Cup,self-centering
04026575329687Vario-Head Cup,self-centering
04026575329670Vario-Head Cup,self-centering
04026575329663Vario-Head Cup,self-centering
04026575329656Vario-Head Cup,self-centering
04026575329649Vario-Head Cup,self-centering
04026575329632107-220/58
04026575329625Vario-Head Cup,self-centering
04026575329618Vario-Head Cup,self-centering
04026575329601Vario-Head Cup,self-centering
04026575328604Vario-Head Cup,self-centering
04026575328598Vario-Head Cup,self-centering
04026575328321Vario-Head Cup,self-centering
04026575328314Vario-Head Cup,self-centering
04026575328307Vario-Head Cup,self-centering
04026575328291Vario-Head Cup,self-centering
04026575328239Vario-Head Cup,self-centering
04026575328222Vario-Head Cup,self-centering
04026575328215Vario-Head Cup,self-centering
04026575328208Vario-Head Cup,self-centering
04026575328192Vario-Head Cup,self-centering
04026575328185Vario-Head Cup,self-centering
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