Guided Surgery Key GSK INT-2

GUDID D785GSKINT20

Guided Surgery Key - Intermediate 2 for drill sizes 3.6mm - 4.6mm

OCO BIOMEDICAL INC

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Primary Device ID	D785GSKINT20
NIH Device Record Key	e605d048-a65c-40a4-86ea-d8fe3d659a70
Commercial Distribution Status	In Commercial Distribution
Brand Name	Guided Surgery Key
Version Model Number	Guided Surgery Key - Intermediate 2
Catalog Number	GSK INT-2
Company DUNS	094146123
Company Name	OCO BIOMEDICAL INC
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D785GSKINT20 [Primary]

FDA Product Code

NDP	Accessories, Implant, Dental, Endosseous