ISI C&B PROSTHETIC KIT 3.25 I-CB PK (F)

GUDID D785325ICBPKF0

3.25MM ISI CROWN & BRIDGE PROSTHETIC KIT

OCO BIOMEDICAL INC

Dental prosthesis/implant abutment screw analog, single-use
Primary Device IDD785325ICBPKF0
NIH Device Record Key1281deb0-03ba-4178-817b-2a1822613870
Commercial Distribution StatusIn Commercial Distribution
Brand NameISI C&B PROSTHETIC KIT
Version Model Number3.25MM ISI CROWN & BRIDGE PROSTHETIC KIT
Catalog Number3.25 I-CB PK (F)
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 Usetrue
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
HIBCCD785325ICBPKF0 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-06
Device Publish Date2024-02-27

On-Brand Devices [ISI C&B PROSTHETIC KIT]

D78540ICBPKF04.0MM ISI CROWN AND BRIDGE PROSTHETIC KIT
D785325ICBPKF03.25MM ISI CROWN & BRIDGE PROSTHETIC KIT
D785325ICBPK03.25MM ISI CROWN & BRIDGE PROSTHETIC KIT

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