SIGNATURE Head - CoCr

GUDID 03701089520690

AMPLITUDE SAS

Metallic femoral head prosthesis
Primary Device ID03701089520690
NIH Device Record Keyd3b6efe6-3abb-41c9-8c42-1003afd0c78d
Commercial Distribution StatusIn Commercial Distribution
Brand NameSIGNATURE Head - CoCr
Version Model Number1-01-152-042
Company DUNS634855407
Company NameAMPLITUDE SAS
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

Customer Support Contacts

Phone+0033475418741
Emailregulatoryaffairs@amplitude-ortho.com

Device Identifiers

Device Issuing AgencyDevice ID
GS103701089520690 [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 Number4
Public Version Date2020-04-06
Device Publish Date2017-12-18

On-Brand Devices [SIGNATURE Head - CoCr]

037010895207131-01-152-044
037010895207061-01-152-043
037010895206901-01-152-042
037010895206831-01-152-041
037010895206761-01-152-034
037010895206691-01-152-033
037010895206521-01-152-032
037010895206451-01-152-031
037010895206381-01-152-024
037010895206211-01-152-023
037010895206141-01-152-022
037010895206071-01-152-021
037010895205911-01-151-013
037010895205841-01-151-012
037010895205771-01-151-011

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