Multiunit CCM Cylinder

GUDID 08800039379243

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

Dental implant system
Primary Device ID08800039379243
NIH Device Record Keyf5306bb0-7fe5-4613-a4fe-cdaf9e3cac9a
Commercial Distribution StatusIn Commercial Distribution
Brand NameMultiunit CCM Cylinder
Version Model NumberMCCN48R
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
GS108800039379243 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800039379243]

Moist Heat or Steam Sterilization


[08800039379243]

Moist Heat or Steam Sterilization


[08800039379243]

Moist Heat or Steam Sterilization


[08800039379243]

Moist Heat or Steam Sterilization


[08800039379243]

Moist Heat or Steam Sterilization


[08800039379243]

Moist Heat or Steam Sterilization


[08800039379243]

Moist Heat or Steam Sterilization


[08800039379243]

Moist Heat or Steam Sterilization


[08800039379243]

Moist Heat or Steam Sterilization


[08800039379243]

Moist Heat or Steam Sterilization


[08800039379243]

Moist Heat or Steam Sterilization


[08800039379243]

Moist Heat or Steam Sterilization


[08800039379243]

Moist Heat or Steam Sterilization


[08800039379243]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-24
Device Publish Date2020-08-14

On-Brand Devices [Multiunit CCM Cylinder]

08800039379243MCCN48R
08800039379236MCCH48R

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