EXP Mount Driver

GUDID 06947600315452

BIO CONCEPT CO.,LTD

Dental implant system
Primary Device ID06947600315452
NIH Device Record Key6f63de67-d310-45ec-b95b-62d34d75ed16
Commercial Distribution StatusIn Commercial Distribution
Brand NameEXP Mount Driver
Version Model Number354070
Company DUNS527603266
Company NameBIO CONCEPT CO.,LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106947600315452 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06947600315452]

Moist Heat or Steam Sterilization


[06947600315452]

Moist Heat or Steam Sterilization


[06947600315452]

Moist Heat or Steam Sterilization


[06947600315452]

Moist Heat or Steam Sterilization


[06947600315452]

Moist Heat or Steam Sterilization


[06947600315452]

Moist Heat or Steam Sterilization


[06947600315452]

Moist Heat or Steam Sterilization


[06947600315452]

Moist Heat or Steam Sterilization


[06947600315452]

Moist Heat or Steam Sterilization


[06947600315452]

Moist Heat or Steam Sterilization


[06947600315452]

Moist Heat or Steam Sterilization


[06947600315452]

Moist Heat or Steam Sterilization


[06947600315452]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-20
Device Publish Date2020-07-10

On-Brand Devices [EXP Mount Driver]

06947600315452354070
06947600315445354060

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