Depth gauge, with distance indicator Φ 2.2/2.8mm

GUDID 06947600301769

BIO CONCEPT CO.,LTD

Dental implant system
Primary Device ID06947600301769
NIH Device Record Key171c6360-e746-4e57-9b30-30e64c341f5c
Commercial Distribution StatusIn Commercial Distribution
Brand NameDepth gauge, with distance indicator Φ 2.2/2.8mm
Version Model Number053020
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
GS106947600301769 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06947600301769]

Moist Heat or Steam Sterilization


[06947600301769]

Moist Heat or Steam Sterilization


[06947600301769]

Moist Heat or Steam Sterilization


[06947600301769]

Moist Heat or Steam Sterilization


[06947600301769]

Moist Heat or Steam Sterilization


[06947600301769]

Moist Heat or Steam Sterilization


[06947600301769]

Moist Heat or Steam Sterilization


[06947600301769]

Moist Heat or Steam Sterilization


[06947600301769]

Moist Heat or Steam Sterilization


[06947600301769]

Moist Heat or Steam Sterilization


[06947600301769]

Moist Heat or Steam Sterilization


[06947600301769]

Moist Heat or Steam Sterilization


[06947600301769]

Moist Heat or Steam Sterilization


[06947600301769]

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

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