IU SB Abutment Φ5.0

GUDID 08800026103561

WARANTEC.Co.,Ltd

Dental implant system
Primary Device ID08800026103561
NIH Device Record Key0f46770d-65cd-4691-b437-c604a2fcf3c9
Commercial Distribution StatusIn Commercial Distribution
Brand NameIU SB Abutment Φ5.0
Version Model NumberIUSB5065
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
GS108800026103561 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800026103561]

Moist Heat or Steam Sterilization


[08800026103561]

Moist Heat or Steam Sterilization


[08800026103561]

Moist Heat or Steam Sterilization


[08800026103561]

Moist Heat or Steam Sterilization


[08800026103561]

Moist Heat or Steam Sterilization


[08800026103561]

Moist Heat or Steam Sterilization


[08800026103561]

Moist Heat or Steam Sterilization


[08800026103561]

Moist Heat or Steam Sterilization


[08800026103561]

Moist Heat or Steam Sterilization


[08800026103561]

Moist Heat or Steam Sterilization


[08800026103561]

Moist Heat or Steam Sterilization


[08800026103561]

Moist Heat or Steam Sterilization


[08800026103561]

Moist Heat or Steam Sterilization


[08800026103561]

Moist Heat or Steam Sterilization


[08800026103561]

Moist Heat or Steam Sterilization


[08800026103561]

Moist Heat or Steam Sterilization


[08800026103561]

Moist Heat or Steam Sterilization


[08800026103561]

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 Φ5.0]

08800026108894IUSB5064
08800026108887IUSB5054
08800026108870IUSB5044
08800026108863IUSB5034
08800026108856IUSB5024
08800026108849IUSB5014
08800026103578IUSB5067
08800026103561IUSB5065
08800026103554IUSB5057
08800026103547IUSB5055
08800026103530IUSB5047
08800026103523IUSB5045
08800026103516IUSB5037
08800026103509IUSB5035
08800026103493IUSB5027
08800026103486IUSB5025
08800026103479IUSB5017
08800026103462IUSB5015

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