Crescendo Femoral Component Cemented - PS Size 5L

GUDID 03701089523899

AMPLITUDE SAS

Uncoated knee femur prosthesis, metallic
Primary Device ID03701089523899
NIH Device Record Key131119ff-fdd1-4b10-a33c-4f01b957cf67
Commercial Distribution StatusIn Commercial Distribution
Brand NameCrescendo Femoral Component Cemented - PS Size 5L
Version Model Number1-01-07-1005
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
GS103701089523899 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-12-11
Device Publish Date2018-10-16

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