Osteotome Tray 6202

GUDID D78562020

Osteotome Tray

OCO BIOMEDICAL INC

Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable
Primary Device IDD78562020
NIH Device Record Keyb2ed269f-dfd6-460d-97c2-c6aad7aa34ab
Commercial Distribution StatusIn Commercial Distribution
Brand NameOsteotome Tray
Version Model NumberOsteotome Tray
Catalog Number6202
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
HIBCCD78562020 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D78562020]

Moist Heat or Steam Sterilization


[D78562020]

Moist Heat or Steam Sterilization


[D78562020]

Moist Heat or Steam Sterilization


[D78562020]

Moist Heat or Steam Sterilization


[D78562020]

Moist Heat or Steam Sterilization


[D78562020]

Moist Heat or Steam Sterilization


[D78562020]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-04
Device Publish Date2024-06-26

Devices Manufactured by OCO BIOMEDICAL INC

D785002CAPWOBN0 - HOUSING CAP WITH O-RING2024-07-04 002 CAP WITH O-RING INSERTED (002BN900)
D785325SB0 - SCAN BODY2024-07-04 TSI/ERI 3.25MM SCAN BODY
D78540SB0 - SCAN BODY2024-07-04 TSI/ERI 4.0MM SCAN BODY
D78550SB0 - SCAN BODY2024-07-04 TSI/ERI 5.0MM SCAN BODY
D78562000 - Complete Surgical Kit2024-07-04 Complete Surgical Kit Caddy
D78562010 - Small Diameter Surgical Kit2024-07-04 Small Diameter Surgical Kit Caddy
D78562020 - Osteotome Tray2024-07-04Osteotome Tray
D78562020 - Osteotome Tray2024-07-04 Osteotome Tray
D78562050 - Engage Compact Kit2024-07-04 Engage Compact Kit Case

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