SURGICAL KIT ENGAGE COMPACT KIT

GUDID D785ENGAGECOMPACTKIT0

ENGAGE SURGICAL INSTRUMENTATION COMPACT KIT

OCO BIOMEDICAL INC

Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Primary Device IDD785ENGAGECOMPACTKIT0
NIH Device Record Key41cc5ede-1bf9-409b-9c8c-68b8c53e850d
Commercial Distribution StatusIn Commercial Distribution
Brand NameSURGICAL KIT
Version Model NumberENGAGE SURGICAL INSTRUMENTATION COMPACT KIT
Catalog NumberENGAGE COMPACT KIT
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 Kittrue
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
HIBCCD785ENGAGECOMPACTKIT0 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D785ENGAGECOMPACTKIT0]

Moist Heat or Steam Sterilization


[D785ENGAGECOMPACTKIT0]

Moist Heat or Steam Sterilization


[D785ENGAGECOMPACTKIT0]

Moist Heat or Steam Sterilization


[D785ENGAGECOMPACTKIT0]

Moist Heat or Steam Sterilization


[D785ENGAGECOMPACTKIT0]

Moist Heat or Steam Sterilization


[D785ENGAGECOMPACTKIT0]

Moist Heat or Steam Sterilization


[D785ENGAGECOMPACTKIT0]

Moist Heat or Steam Sterilization


[D785ENGAGECOMPACTKIT0]

Moist Heat or Steam Sterilization


[D785ENGAGECOMPACTKIT0]

Moist Heat or Steam Sterilization


[D785ENGAGECOMPACTKIT0]

Moist Heat or Steam Sterilization


[D785ENGAGECOMPACTKIT0]

Moist Heat or Steam Sterilization


[D785ENGAGECOMPACTKIT0]

Moist Heat or Steam Sterilization


[D785ENGAGECOMPACTKIT0]

Moist Heat or Steam Sterilization


[D785ENGAGECOMPACTKIT0]

Moist Heat or Steam Sterilization


[D785ENGAGECOMPACTKIT0]

Moist Heat or Steam Sterilization


[D785ENGAGECOMPACTKIT0]

Moist Heat or Steam Sterilization


[D785ENGAGECOMPACTKIT0]

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

On-Brand Devices [SURGICAL KIT]

D785GUIDEDSURGERYKIT0GUIDED SURGERY SURGICAL INSTRUMENTATION KIT
D785ENGAGECOMPACTKIT0ENGAGE SURGICAL INSTRUMENTATION COMPACT KIT

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