Multi Abutment Outer Driver

GUDID 06947600317890

BIO CONCEPT CO.,LTD

Surgical screwdriver, reusable
Primary Device ID06947600317890
NIH Device Record Keyc98e540f-53e0-4001-a312-60b7d42b7dbd
Commercial Distribution StatusIn Commercial Distribution
Brand NameMulti Abutment Outer Driver
Version Model Number354050U
Company DUNS527603266
Company NameBIO CONCEPT CO.,LTD
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
GS106947600317890 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06947600317890]

Moist Heat or Steam Sterilization


[06947600317890]

Moist Heat or Steam Sterilization


[06947600317890]

Moist Heat or Steam Sterilization


[06947600317890]

Moist Heat or Steam Sterilization


[06947600317890]

Moist Heat or Steam Sterilization


[06947600317890]

Moist Heat or Steam Sterilization


[06947600317890]

Moist Heat or Steam Sterilization


[06947600317890]

Moist Heat or Steam Sterilization


[06947600317890]

Moist Heat or Steam Sterilization


[06947600317890]

Moist Heat or Steam Sterilization


[06947600317890]

Moist Heat or Steam Sterilization


[06947600317890]

Moist Heat or Steam Sterilization


[06947600317890]

Moist Heat or Steam Sterilization


[06947600317890]

Moist Heat or Steam Sterilization


[06947600317890]

Moist Heat or Steam Sterilization


[06947600317890]

Moist Heat or Steam Sterilization


[06947600317890]

Moist Heat or Steam Sterilization


[06947600317890]

Moist Heat or Steam Sterilization


[06947600317890]

Moist Heat or Steam Sterilization


[06947600317890]

Moist Heat or Steam Sterilization


[06947600317890]

Moist Heat or Steam Sterilization


[06947600317890]

Moist Heat or Steam Sterilization


[06947600317890]

Moist Heat or Steam Sterilization


[06947600317890]

Moist Heat or Steam Sterilization


[06947600317890]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-29
Device Publish Date2024-11-21

On-Brand Devices [Multi Abutment Outer Driver]

06947600316206354050
06947600317890354050U

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.