Multiunit Abutment Temporary Cylinder

GUDID 08800039379366

InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)

Dental implant system
Primary Device ID08800039379366
NIH Device Record Keye61ff732-beac-4234-a83c-2e2bbb6b7440
Commercial Distribution StatusIn Commercial Distribution
Brand NameMultiunit Abutment Temporary Cylinder
Version Model NumberMCTH48R
Company DUNS631169224
Company NameInnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)
Device Count1
DM Exempttrue
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 Numbertrue
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
GS108800039379366 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800039379366]

Moist Heat or Steam Sterilization


[08800039379366]

Moist Heat or Steam Sterilization


[08800039379366]

Moist Heat or Steam Sterilization


[08800039379366]

Moist Heat or Steam Sterilization


[08800039379366]

Moist Heat or Steam Sterilization


[08800039379366]

Moist Heat or Steam Sterilization


[08800039379366]

Moist Heat or Steam Sterilization


[08800039379366]

Moist Heat or Steam Sterilization


[08800039379366]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-05
Device Publish Date2021-01-28

On-Brand Devices [Multiunit Abutment Temporary Cylinder]

08800039379373MCTN48R
08800039379366MCTH48R

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