Vario-Cup System

GUDID 04026575329809

WALDEMAR LINK GmbH & Co. KG

Bipolar femoral head outer component, hemiarthroplasty
Primary Device ID04026575329809
NIH Device Record Keya6b37f52-c03d-44ef-9665-468add0142c7
Commercial Distribution StatusIn Commercial Distribution
Brand NameVario-Cup System
Version Model Number107-230/52
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
GS104026575329809 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-22
Device Publish Date2023-03-14

On-Brand Devices [Vario-Cup System]

04026575395910Safety Ring, for Head Ø 22mm
04026575352791Vario-Cup, ID22 OD43
04026575352784Vario-Cup, ID22 OD42
04026575352777Vario-Cup, ID22 OD41
04026575352760Vario-Cup, ID22 OD40
04026575352753Vario-Cup, ID22 OD39
04026575395903Safety Ring, UHMWPE, cementless
04026575329939107-230/65
04026575329922107-230/64
04026575329915107-230/63
04026575329908107-230/62
04026575329892107-230/61
04026575329885107-230/60
04026575329878107-230/59
04026575329861107-230/58
04026575329854107-230/57
04026575329847107-230/56
04026575329830107-230/55
04026575329823107-230/54
04026575329816107-230/53
04026575329809107-230/52
04026575329793107-230/51
04026575329786107-230/50
04026575329779107-230/49

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