Fine Osteotomy disposable instruments - Proximal tibia 015-410-602

GUDID 00688346002409

Cutting guides, drilling tower, Open validators and retaining screws

Laboratoires Bodycad Inc

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Primary Device ID00688346002409
NIH Device Record Key4f7c4c50-10f3-4657-9ed1-5f7840d1c1ec
Commercial Distribution StatusIn Commercial Distribution
Brand NameFine Osteotomy disposable instruments - Proximal tibia
Version Model Number015-410-602
Catalog Number015-410-602
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100688346002409 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00688346002409]

Moist Heat or Steam Sterilization


[00688346002409]

Moist Heat or Steam Sterilization


[00688346002409]

Moist Heat or Steam Sterilization


[00688346002409]

Moist Heat or Steam Sterilization


[00688346002409]

Moist Heat or Steam Sterilization


[00688346002409]

Moist Heat or Steam Sterilization


[00688346002409]

Moist Heat or Steam Sterilization


[00688346002409]

Moist Heat or Steam Sterilization


[00688346002409]

Moist Heat or Steam Sterilization


[00688346002409]

Moist Heat or Steam Sterilization


[00688346002409]

Moist Heat or Steam Sterilization


[00688346002409]

Moist Heat or Steam Sterilization


[00688346002409]

Moist Heat or Steam Sterilization


[00688346002409]

Moist Heat or Steam Sterilization


[00688346002409]

Moist Heat or Steam Sterilization


[00688346002409]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-13
Device Publish Date2021-12-03

On-Brand Devices [Fine Osteotomy disposable instruments - Proximal tibia]

00688346000559Proximal tibia, disposable instruments (cutting guides, screws, drilling tower)
00688346000542Proximal tibia, disposable instruments (cutting guides, screws, drilling tower, validators)
00688346000139Proximal tibia, disposable instruments (cutting guides, screws, drilling tower, pre-drill guide,
00688346002416Cutting guides, drilling towers and retaining screws
00688346002409Cutting guides, drilling tower, Open validators and retaining screws
00688346002393Cutting guides, drilling towers, pre-drill guide, open validators and retaining screws

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