IU SB Abutment Φ4.0

GUDID 08800026103400

WARANTEC.Co.,Ltd

Dental implant system
Primary Device ID08800026103400
NIH Device Record Keyeecccea2-1e8c-4a0b-a34c-0760dd269a12
Commercial Distribution StatusIn Commercial Distribution
Brand NameIU SB Abutment Φ4.0
Version Model NumberIUSB4045
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
GS108800026103400 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800026103400]

Moist Heat or Steam Sterilization


[08800026103400]

Moist Heat or Steam Sterilization


[08800026103400]

Moist Heat or Steam Sterilization


[08800026103400]

Moist Heat or Steam Sterilization


[08800026103400]

Moist Heat or Steam Sterilization


[08800026103400]

Moist Heat or Steam Sterilization


[08800026103400]

Moist Heat or Steam Sterilization


[08800026103400]

Moist Heat or Steam Sterilization


[08800026103400]

Moist Heat or Steam Sterilization


[08800026103400]

Moist Heat or Steam Sterilization


[08800026103400]

Moist Heat or Steam Sterilization


[08800026103400]

Moist Heat or Steam Sterilization


[08800026103400]

Moist Heat or Steam Sterilization


[08800026103400]

Moist Heat or Steam Sterilization


[08800026103400]

Moist Heat or Steam Sterilization


[08800026103400]

Moist Heat or Steam Sterilization


[08800026103400]

Moist Heat or Steam Sterilization


[08800026103400]

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 Φ4.0]

08800026108832IUSB4064A
08800026108825IUSB4064
08800026108818IUSB4054A
08800026108801IUSB4054
08800026108795IUSB4044A
08800026108788IUSB4044
08800026108771IUSB4034A
08800026108764IUSB4034
08800026108757IUSB4024A
08800026108740IUSB4024
08800026108733IUSB4014A
08800026108726IUSB4014
08800026103813IUSB4067A
08800026103806IUSB4065A
08800026103790IUSB4057A
08800026103783IUSB4055A
08800026103776IUSB4047A
08800026103769IUSB4045A
08800026103752IUSB4037A
08800026103745IUSB4035A
08800026103738IUSB4027A
08800026103721IUSB4025A
08800026103714IUSB4017A
08800026103707IUSB4015A
08800026103448IUSB4065
08800026103431IUSB4057
08800026103424IUSB4055
08800026103417IUSB4047
08800026103400IUSB4045
08800026103394IUSB4037
08800026103387IUSB4035
08800026103370IUSB4027
08800026103363IUSB4025
08800026103356IUSB4017
08800026103349IUSB4015

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