DM Converter – TiN coated

GUDID 07630971256361

DM Converter F/DME - TiN coated

Medacta International SA

Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner
Primary Device ID07630971256361
NIH Device Record Key3a544c9d-1c00-4a66-a790-69b707f4e835
Commercial Distribution StatusIn Commercial Distribution
Brand NameDM Converter – TiN coated
Version Model Number01.32.4248CF
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
GS107630971256361 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-02
Device Publish Date2022-07-25

On-Brand Devices [DM Converter – TiN coated]

07630971256392DM Converter K/DML - TiN coated
07630971256385DM Converter J/DMH - TiN coated
07630971256378DM Converter G/DMF - TiN coated
07630971256361DM Converter F/DME - TiN coated
07630971256354DM Converter E/DMC - TiN coated
07630971256347DM Converter D/DMB - TiN coated

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