S/SP Tap for ratchet, long

GUDID 06947600301677

BIO CONCEPT CO.,LTD

Dental implant system
Primary Device ID06947600301677
NIH Device Record Keyee06f6e6-0684-49ce-b384-0444e630033a
Commercial Distribution StatusIn Commercial Distribution
Brand NameS/SP Tap for ratchet, long
Version Model Number051250
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 Batchfalse
Serial Numbertrue
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
GS106947600301677 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06947600301677]

Moist Heat or Steam Sterilization


[06947600301677]

Moist Heat or Steam Sterilization


[06947600301677]

Moist Heat or Steam Sterilization


[06947600301677]

Moist Heat or Steam Sterilization


[06947600301677]

Moist Heat or Steam Sterilization


[06947600301677]

Moist Heat or Steam Sterilization


[06947600301677]

Moist Heat or Steam Sterilization


[06947600301677]

Moist Heat or Steam Sterilization


[06947600301677]

Moist Heat or Steam Sterilization


[06947600301677]

Moist Heat or Steam Sterilization


[06947600301677]

Moist Heat or Steam Sterilization


[06947600301677]

Moist Heat or Steam Sterilization


[06947600301677]

Moist Heat or Steam Sterilization


[06947600301677]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-11-19
Device Publish Date2016-09-01

On-Brand Devices [S/SP Tap for ratchet, long ]

06947600301738051310
06947600301707051280
06947600301677051250

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