BC Reflex Uni 018-001

GUDID 00688346001334

Laboratoires Bodycad Inc

Unicondylar knee prosthesis
Primary Device ID00688346001334
NIH Device Record Key5a9b7b1a-c63e-445f-9717-f5bc1c5f3a46
Commercial Distribution StatusIn Commercial Distribution
Brand NameBC Reflex Uni
Version Model Number018-001
Catalog Number018-001
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 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
GS100688346001334 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-22
Device Publish Date2021-12-13

On-Brand Devices [BC Reflex Uni ]

62845195000066018-001
00688346000061018-001
00688346002072018-001
00688346001358018-001
00688346001341018-001
00688346001334018-001
00688346001204018-001

Trademark Results [BC Reflex Uni]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BC REFLEX UNI
BC REFLEX UNI
88584187 not registered Live/Pending
Laboratoires Bodycad Inc.
2019-08-19
BC REFLEX UNI
BC REFLEX UNI
88584147 not registered Live/Pending
Laboratoires Bodycad Inc.
2019-08-19

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