Guide Pin,Mini,Long

GUDID 06947600312796

BIO CONCEPT CO.,LTD

Dental implant system
Primary Device ID06947600312796
NIH Device Record Key01b945b2-aca2-4411-9b14-08021303d97a
Commercial Distribution StatusIn Commercial Distribution
Brand NameGuide Pin,Mini,Long
Version Model Number361120-2
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 Usetrue
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
GS106947600312796 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, 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 Date2020-07-20
Device Publish Date2020-07-10

On-Brand Devices [Guide Pin,Mini,Long]

06947600312819361120-4
06947600312802361120-3
06947600312796361120-2

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