RN Healing cap

GUDID 06947600301011

BIO CONCEPT CO.,LTD

Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system
Primary Device ID06947600301011
NIH Device Record Keybbc882d7-e936-4fef-92d3-c09d6114aebe
Commercial Distribution StatusIn Commercial Distribution
Brand NameRN Healing cap
Version Model Number022030
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
GS106947600301011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06947600301011]

Moist Heat or Steam Sterilization


[06947600301011]

Moist Heat or Steam Sterilization


[06947600301011]

Moist Heat or Steam Sterilization


[06947600301011]

Moist Heat or Steam Sterilization


[06947600301011]

Moist Heat or Steam Sterilization


[06947600301011]

Moist Heat or Steam Sterilization


[06947600301011]

Moist Heat or Steam Sterilization


[06947600301011]

Moist Heat or Steam Sterilization


[06947600301011]

Moist Heat or Steam Sterilization


[06947600301011]

Moist Heat or Steam Sterilization


[06947600301011]

Moist Heat or Steam Sterilization


[06947600301011]

Moist Heat or Steam Sterilization


[06947600301011]

Moist Heat or Steam Sterilization


[06947600301011]

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 [RN Healing cap]

06947600301035022050
06947600301028022040
06947600301011022030
06947600301004022020

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