Fine Osteotomy disposable instruments - Distal femur 015-330-603

GUDID 00688346000535

Distal femur, disposable instruments (cutting guides, screws, drilling tower)

Laboratoires Bodycad Inc

Custom-made orthopaedic/craniofacial surgical guide
Primary Device ID00688346000535
NIH Device Record Keyb59bf63b-2496-4ff6-a2da-f10d20ae7435
Commercial Distribution StatusIn Commercial Distribution
Brand NameFine Osteotomy disposable instruments - Distal femur
Version Model Number015-330-603
Catalog Number015-330-603
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
GS100688346000535 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00688346000535]

Moist Heat or Steam Sterilization


[00688346000535]

Moist Heat or Steam Sterilization


[00688346000535]

Moist Heat or Steam Sterilization


[00688346000535]

Moist Heat or Steam Sterilization


[00688346000535]

Moist Heat or Steam Sterilization


[00688346000535]

Moist Heat or Steam Sterilization


[00688346000535]

Moist Heat or Steam Sterilization


[00688346000535]

Moist Heat or Steam Sterilization


[00688346000535]

Moist Heat or Steam Sterilization


[00688346000535]

Moist Heat or Steam Sterilization


[00688346000535]

Moist Heat or Steam Sterilization


[00688346000535]

Moist Heat or Steam Sterilization


[00688346000535]

Moist Heat or Steam Sterilization


[00688346000535]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-12-04
Device Publish Date2020-05-20

On-Brand Devices [Fine Osteotomy disposable instruments - Distal femur]

00688346000535Distal femur, disposable instruments (cutting guides, screws, drilling tower)
00688346000528Distal femur, disposable instruments (cutting guides, screws, drilling tower, validators)
00688346000115Distal femur, disposable instruments (cutting guides, screws, drilling tower, pre-drill guide, v
00688346002249cutting guides, drilling tower and retaining screws,
00688346002232cutting guides, drilling tower, open validators and retaining screws
00688346002225Cutting guides, drilling towers, pre-drill guide, open validators and retaining screws.

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