Mpact Constrained Liner

GUDID 07630542722653

Constrained PE liner Ø22/D

Medacta International SA

Constrained polyethylene acetabular liner
Primary Device ID07630542722653
NIH Device Record Keybb2eb0e1-99a8-4993-abcb-81ce7579f7b7
Commercial Distribution StatusIn Commercial Distribution
Brand NameMpact Constrained Liner
Version Model Number01.32.2241CL
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 Datetrue
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
GS107630542722653 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWZProsthesis, hip, constrained, cemented or uncemented, metal/polymer

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-14
Device Publish Date2025-08-06

On-Brand Devices [Mpact Constrained Liner]

07630542722769Constrained 10° PE liner Ø28/F
07630542722752Constrained 10° PE liner Ø28/K
07630542722745Constrained PE liner Ø28/K
07630542722738Constrained 10° PE liner Ø28/J
07630542722721Constrained PE liner Ø28/J
07630542722714Constrained 10° PE liner Ø28/G
07630542722707Constrained PE liner Ø28/G
07630542722691Constrained PE liner Ø28/F
07630542722684Constrained 10° PE liner Ø22/E
07630542722677Constrained PE liner Ø22/E
07630542722660Constrained 10° PE liner Ø22/D
07630542722653Constrained PE liner Ø22/D

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