Abutment Screw

GUDID 08800090601611

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

Dental implant system
Primary Device ID08800090601611
NIH Device Record Keyd5fd1600-ebe7-4b1f-adf8-7b4c586877f8
Commercial Distribution StatusIn Commercial Distribution
Brand NameAbutment Screw
Version Model NumberATCS
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 Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800090601611 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800090601611]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-01
Device Publish Date2020-06-23

On-Brand Devices [Abutment Screw]

08800090601611ATCS
08800177388879ATCS5
08800039368933MPCSN
08800039364522MPCS
08800039364539OIAS400

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