IU Temporary cylinder_Non hex

GUDID 08800026104902

WARANTEC.Co.,Ltd

Dental implant system
Primary Device ID08800026104902
NIH Device Record Key6c8e4ba7-3266-4c0f-8a44-d5e8eb056c8b
Commercial Distribution StatusIn Commercial Distribution
Brand NameIU Temporary cylinder_Non hex
Version Model NumberIUTCA
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
GS108800026104902 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800026104902]

Moist Heat or Steam Sterilization


[08800026104902]

Moist Heat or Steam Sterilization


[08800026104902]

Moist Heat or Steam Sterilization


[08800026104902]

Moist Heat or Steam Sterilization


[08800026104902]

Moist Heat or Steam Sterilization


[08800026104902]

Moist Heat or Steam Sterilization


[08800026104902]

Moist Heat or Steam Sterilization


[08800026104902]

Moist Heat or Steam Sterilization


[08800026104902]

Moist Heat or Steam Sterilization


[08800026104902]

Moist Heat or Steam Sterilization


[08800026104902]

Moist Heat or Steam Sterilization


[08800026104902]

Moist Heat or Steam Sterilization


[08800026104902]

Moist Heat or Steam Sterilization


[08800026104902]

Moist Heat or Steam Sterilization


[08800026104902]

Moist Heat or Steam Sterilization


[08800026104902]

Moist Heat or Steam Sterilization


[08800026104902]

Moist Heat or Steam Sterilization


[08800026104902]

Moist Heat or Steam Sterilization


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 Temporary cylinder_Non hex]

08800026104919IUTC
08800026104902IUTCA

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