Guided Surgery Ratchet GS5.0 R8

GUDID D785GS50R80

5.0 Guided Surgery Ratchet 8mm Length

OCO BIOMEDICAL INC

Surgical screwdriver, reusable
Primary Device IDD785GS50R80
NIH Device Record Key739da5b4-701c-47ff-b124-e077c208c766
Commercial Distribution StatusIn Commercial Distribution
Brand NameGuided Surgery Ratchet
Version Model Number5.0 Guided Surgery Ratchet
Catalog NumberGS5.0 R8
Company DUNS094146123
Company NameOCO BIOMEDICAL INC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
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
HIBCCD785GS50R80 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D785GS50R80]

Moist Heat or Steam Sterilization


[D785GS50R80]

Moist Heat or Steam Sterilization


[D785GS50R80]

Moist Heat or Steam Sterilization


[D785GS50R80]

Moist Heat or Steam Sterilization


[D785GS50R80]

Moist Heat or Steam Sterilization


[D785GS50R80]

Moist Heat or Steam Sterilization


[D785GS50R80]

Moist Heat or Steam Sterilization


[D785GS50R80]

Moist Heat or Steam Sterilization


[D785GS50R80]

Moist Heat or Steam Sterilization


[D785GS50R80]

Moist Heat or Steam Sterilization


[D785GS50R80]

Moist Heat or Steam Sterilization


[D785GS50R80]

Moist Heat or Steam Sterilization


[D785GS50R80]

Moist Heat or Steam Sterilization


[D785GS50R80]

Moist Heat or Steam Sterilization


[D785GS50R80]

Moist Heat or Steam Sterilization


[D785GS50R80]

Moist Heat or Steam Sterilization


[D785GS50R80]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-20
Device Publish Date2024-03-12

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D785GS40R904.0 Guided Surgery Ratchet 9mm Length
D785GS40R804.0 Guided Surgery Ratchet 8mm Length
D785GS40R1004.0 Guided Surgery Ratchet 10mm Length
D785GS325R903.25 Guided Surgery Ratchet 9mm Length
D785GS325R1003.25 Guided Surgery Ratchet 10mm Length

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