Bodycad Unicompartmental Knee System 010003

GUDID 62845195010003

Laboratoires Bodycad Inc

Unicondylar knee prosthesis
Primary Device ID62845195010003
NIH Device Record Keyc7f261c8-ccc8-4f36-bcd2-5bfecce4f136
Commercial Distribution StatusIn Commercial Distribution
Brand NameBodycad Unicompartmental Knee System
Version Model Number010003
Catalog Number010003
Company DUNS202981171
Company NameLaboratoires Bodycad Inc
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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS162845195010003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-04-13

On-Brand Devices [Bodycad Unicompartmental Knee System]

62845195010003010003
00688346010008010003

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.