Versafitcup Double Mobility Shells

GUDID 07630030808098

Acetabular shell cementless Ø 52

Medacta International SA

Acetabular shell
Primary Device ID07630030808098
NIH Device Record Key6f42cc65-44fe-4322-9226-50c37070c983
Commercial Distribution StatusIn Commercial Distribution
Brand NameVersafitcup Double Mobility Shells
Version Model Number01.26.52MB
Company DUNS488227125
Company NameMedacta International SA
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 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
GS107630030808098 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-11-18

On-Brand Devices [Versafitcup Double Mobility Shells]

07630030808296Acetabular shell cementless Ø 64
07630030808265Acetabular shell cementless Ø 62
07630030808234Acetabular shell cementless Ø 60
07630030808203Acetabular shell cementless Ø 58
07630030808173Acetabular shell cementless Ø 56
07630030808128Acetabular shell cementless Ø 54
07630030808098Acetabular shell cementless Ø 52
07630030808067Acetabular shell cementless Ø 50
07630030808036Acetabular shell cementless Ø 48
07630030808012Acetabular shell cementless Ø 46

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