IU SB Abutment_hex Φ4.0

GUDID 08800026109136

WARANTEC.Co.,Ltd

Dental implant system
Primary Device ID08800026109136
NIH Device Record Keyc61ddd6d-0f1f-4eae-bdb4-9e17545d063e
Commercial Distribution StatusIn Commercial Distribution
Brand NameIU SB Abutment_hex Φ4.0
Version Model NumberIUSB4024H
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
GS108800026109136 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800026109136]

Moist Heat or Steam Sterilization


[08800026109136]

Moist Heat or Steam Sterilization


[08800026109136]

Moist Heat or Steam Sterilization


[08800026109136]

Moist Heat or Steam Sterilization


[08800026109136]

Moist Heat or Steam Sterilization


[08800026109136]

Moist Heat or Steam Sterilization


[08800026109136]

Moist Heat or Steam Sterilization


[08800026109136]

Moist Heat or Steam Sterilization


[08800026109136]

Moist Heat or Steam Sterilization


[08800026109136]

Moist Heat or Steam Sterilization


[08800026109136]

Moist Heat or Steam Sterilization


[08800026109136]

Moist Heat or Steam Sterilization


[08800026109136]

Moist Heat or Steam Sterilization


[08800026109136]

Moist Heat or Steam Sterilization


[08800026109136]

Moist Heat or Steam Sterilization


[08800026109136]

Moist Heat or Steam Sterilization


[08800026109136]

Moist Heat or Steam Sterilization


[08800026109136]

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 SB Abutment_hex Φ4.0]

08800026109228IUSB4064HA
08800026109211IUSB4064H
08800026109204IUSB4054HA
08800026109198IUSB4054H
08800026109181IUSB4044HA
08800026109174IUSB4044H
08800026109167IUSB4034HA
08800026109150IUSB4034H
08800026109143IUSB4024HA
08800026109136IUSB4024H
08800026109129IUSB4014HA
08800026109112IUSB4014H
08800026103332IUSB4067HA
08800026103325IUSB4065HA
08800026103318IUSB4057HA
08800026103301IUSB4055HA
08800026103295IUSB4047HA
08800026103288IUSB4045HA
08800026103271IUSB4037HA
08800026103264IUSB4035HA
08800026103257IUSB4027HA
08800026103240IUSB4025HA
08800026103233IUSB4017HA
08800026103226IUSB4015HA
08800026102977IUSB4067H
08800026102960IUSB4065H
08800026102953IUSB4057H
08800026102946IUSB4055H
08800026102939IUSB4047H
08800026102922IUSB4045H
08800026102915IUSB4037H
08800026102908IUSB4035H
08800026102892IUSB4027H
08800026102885IUSB4025H
08800026102878IUSB4017H
08800026102861IUSB4015H

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