IU Cover Screw

GUDID 08800026106500

WARANTEC.Co.,Ltd

Dental implant system
Primary Device ID08800026106500
NIH Device Record Key561bceda-7658-4ad3-b552-8f5e464b3efe
Commercial Distribution StatusIn Commercial Distribution
Brand NameIU Cover Screw
Version Model NumberIUCSA
Company DUNS688857820
Company NameWARANTEC.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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800026106500 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-20
Device Publish Date2023-04-12

On-Brand Devices [IU Cover Screw]

08800026106500IUCSA
08800026106494IUCS

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