BC Reflex Uni Reusable Surgical Instrument Set 027-003

GUDID 00688346002478

Reusable Surgical Instrument Set

Laboratoires Bodycad Inc

Unicondylar knee prosthesis
Primary Device ID00688346002478
NIH Device Record Key2e8cd6c0-d57e-4f71-b391-a614ee7eb771
Commercial Distribution StatusIn Commercial Distribution
Brand NameBC Reflex Uni Reusable Surgical Instrument Set
Version Model Number027-003
Catalog Number027-003
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 Usefalse
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
GS100688346002478 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00688346002478]

Moist Heat or Steam Sterilization


[00688346002478]

Moist Heat or Steam Sterilization


[00688346002478]

Moist Heat or Steam Sterilization


[00688346002478]

Moist Heat or Steam Sterilization


[00688346002478]

Moist Heat or Steam Sterilization


[00688346002478]

Moist Heat or Steam Sterilization


[00688346002478]

Moist Heat or Steam Sterilization


[00688346002478]

Moist Heat or Steam Sterilization


[00688346002478]

Moist Heat or Steam Sterilization


[00688346002478]

Moist Heat or Steam Sterilization


[00688346002478]

Moist Heat or Steam Sterilization


[00688346002478]

Moist Heat or Steam Sterilization


[00688346002478]

Moist Heat or Steam Sterilization


[00688346002478]

Moist Heat or Steam Sterilization


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 Reusable Surgical Instrument Set]

00688346001198027-003
00688346000566027-003
00688346002478Reusable Surgical Instrument Set

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