BC Equator Square Screwdriver for ratchet

GUDID 06947600306573

BIO CONCEPT CO.,LTD

Dental implant system
Primary Device ID06947600306573
NIH Device Record Key82598ca8-88ef-4ddd-9c10-a345df83f4f9
Commercial Distribution StatusIn Commercial Distribution
Brand NameBC Equator Square Screwdriver for ratchet
Version Model Number055130
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
GS106947600306573 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06947600306573]

Moist Heat or Steam Sterilization


[06947600306573]

Moist Heat or Steam Sterilization


[06947600306573]

Moist Heat or Steam Sterilization


[06947600306573]

Moist Heat or Steam Sterilization


[06947600306573]

Moist Heat or Steam Sterilization


[06947600306573]

Moist Heat or Steam Sterilization


[06947600306573]

Moist Heat or Steam Sterilization


[06947600306573]

Moist Heat or Steam Sterilization


[06947600306573]

Moist Heat or Steam Sterilization


[06947600306573]

Moist Heat or Steam Sterilization


[06947600306573]

Moist Heat or Steam Sterilization


[06947600306573]

Moist Heat or Steam Sterilization


[06947600306573]

Moist Heat or Steam Sterilization


[06947600306573]

Moist Heat or Steam Sterilization


[06947600306573]

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

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