AMIStem-H Proximal Coating

GUDID 07630030804359

AMIStem-H Proximal Coating STD stem #0

Medacta International SA

Press-fit hip femur prosthesis, one-piece
Primary Device ID07630030804359
NIH Device Record Keyc2e2f3e4-507b-43de-a361-57df156e4250
Commercial Distribution StatusIn Commercial Distribution
Brand NameAMIStem-H Proximal Coating
Version Model Number01.18.170
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
GS107630030804359 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-11-01
Device Publish Date2021-10-22

On-Brand Devices [AMIStem-H Proximal Coating]

07630030804458AMIStem-H Proximal Coating LAT stem #0
07630030804359AMIStem-H Proximal Coating STD stem #0
07630030804342AMIStem-H Proximal Coating STD stem #00

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