Mpact Double Mobility Shells

GUDID 07630030861017

Double Mobility Acetabular shell Ø60

Medacta International SA

Acetabular shell
Primary Device ID07630030861017
NIH Device Record Key04677b4e-872e-4751-a09a-2c2fb157d29e
Commercial Distribution StatusIn Commercial Distribution
Brand NameMpact Double Mobility Shells
Version Model Number01.32.160MB
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
GS107630030861017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

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 Date2015-09-21

On-Brand Devices [Mpact Double Mobility Shells]

07630030861048Double Mobility Acetabular shell Ø66
07630030861031Double Mobility Acetabular shell Ø64
07630030861024Double Mobility Acetabular shell Ø62
07630030861017Double Mobility Acetabular shell Ø60
07630030861000Double Mobility Acetabular shell Ø58
07630030860997Double Mobility Acetabular shell Ø56
07630030860980Double Mobility Acetabular shell Ø54
07630030860973Double Mobility Acetabular shell Ø52
07630030860966Double Mobility Acetabular shell Ø50
07630030860959Double Mobility Acetabular shell Ø48
07630030860942Double Mobility Acetabular shell Ø46
07630030860935Double Mobility Acetabular shell Ø44
07630030860928Double Mobility Acetabular shell Ø42

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