BLT Tap

GUDID 06947600304166

BIO CONCEPT CO.,LTD

Dental implant system
Primary Device ID06947600304166
NIH Device Record Key622eca0b-04f9-4c1f-9452-8c1400a438f7
Commercial Distribution StatusIn Commercial Distribution
Brand NameBLT Tap
Version Model Number151160
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106947600304166 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06947600304166]

Moist Heat or Steam Sterilization


[06947600304166]

Moist Heat or Steam Sterilization


[06947600304166]

Moist Heat or Steam Sterilization


[06947600304166]

Moist Heat or Steam Sterilization


[06947600304166]

Moist Heat or Steam Sterilization


[06947600304166]

Moist Heat or Steam Sterilization


[06947600304166]

Moist Heat or Steam Sterilization


[06947600304166]

Moist Heat or Steam Sterilization


[06947600304166]

Moist Heat or Steam Sterilization


[06947600304166]

Moist Heat or Steam Sterilization


[06947600304166]

Moist Heat or Steam Sterilization


[06947600304166]

Moist Heat or Steam Sterilization


[06947600304166]

Moist Heat or Steam Sterilization


[06947600304166]

Moist Heat or Steam Sterilization


[06947600304166]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-13
Device Publish Date2022-09-05

On-Brand Devices [BLT Tap]

06947600304173151170
06947600304166151160
06947600304159151150

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