Guided Surgery Ratchet GS3.25 R10

GUDID D785GS325R100

3.25 Guided Surgery Ratchet 10mm Length

OCO BIOMEDICAL INC

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Primary Device IDD785GS325R100
NIH Device Record Key4c069671-9dae-48e3-994d-dcdb16ff1bbd
Commercial Distribution StatusIn Commercial Distribution
Brand NameGuided Surgery Ratchet
Version Model Number3.25 Guided Surgery Ratchet
Catalog NumberGS3.25 R10
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
HIBCCD785GS325R100 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D785GS325R100]

Moist Heat or Steam Sterilization


[D785GS325R100]

Moist Heat or Steam Sterilization


[D785GS325R100]

Moist Heat or Steam Sterilization


[D785GS325R100]

Moist Heat or Steam Sterilization


[D785GS325R100]

Moist Heat or Steam Sterilization


[D785GS325R100]

Moist Heat or Steam Sterilization


[D785GS325R100]

Moist Heat or Steam Sterilization


[D785GS325R100]

Moist Heat or Steam Sterilization


[D785GS325R100]

Moist Heat or Steam Sterilization


[D785GS325R100]

Moist Heat or Steam Sterilization


[D785GS325R100]

Moist Heat or Steam Sterilization


[D785GS325R100]

Moist Heat or Steam Sterilization


[D785GS325R100]

Moist Heat or Steam Sterilization


[D785GS325R100]

Moist Heat or Steam Sterilization


[D785GS325R100]

Moist Heat or Steam Sterilization


[D785GS325R100]

Moist Heat or Steam Sterilization


[D785GS325R100]

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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