Depth Gauge

GUDID 06947600315223

BIO CONCEPT CO.,LTD

Dental implant system
Primary Device ID06947600315223
NIH Device Record Key4feb3a61-0a6a-4aa4-851b-9a98fb05196f
Commercial Distribution StatusIn Commercial Distribution
Brand NameDepth Gauge
Version Model Number352040
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
GS106947600315223 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06947600315223]

Moist Heat or Steam Sterilization


[06947600315223]

Moist Heat or Steam Sterilization


[06947600315223]

Moist Heat or Steam Sterilization


[06947600315223]

Moist Heat or Steam Sterilization


[06947600315223]

Moist Heat or Steam Sterilization


[06947600315223]

Moist Heat or Steam Sterilization


[06947600315223]

Moist Heat or Steam Sterilization


[06947600315223]

Moist Heat or Steam Sterilization


[06947600315223]

Moist Heat or Steam Sterilization


[06947600315223]

Moist Heat or Steam Sterilization


[06947600315223]

Moist Heat or Steam Sterilization


[06947600315223]

Moist Heat or Steam Sterilization


[06947600315223]

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 [Depth Gauge]

06947600315223352040
06947600316015352030
06947600304227152050
06947600304210152040
06947600304203152030

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