IU SB Abutment_Non hex Φ5.0

GUDID 08800026103967

WARANTEC.Co.,Ltd

Dental implant system
Primary Device ID08800026103967
NIH Device Record Key35f674e0-031e-4176-b446-fbbcef674028
Commercial Distribution StatusIn Commercial Distribution
Brand NameIU SB Abutment_Non hex Φ5.0
Version Model NumberIUSB5025N
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
GS108800026103967 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800026103967]

Moist Heat or Steam Sterilization


[08800026103967]

Moist Heat or Steam Sterilization


[08800026103967]

Moist Heat or Steam Sterilization


[08800026103967]

Moist Heat or Steam Sterilization


[08800026103967]

Moist Heat or Steam Sterilization


[08800026103967]

Moist Heat or Steam Sterilization


[08800026103967]

Moist Heat or Steam Sterilization


[08800026103967]

Moist Heat or Steam Sterilization


[08800026103967]

Moist Heat or Steam Sterilization


[08800026103967]

Moist Heat or Steam Sterilization


[08800026103967]

Moist Heat or Steam Sterilization


[08800026103967]

Moist Heat or Steam Sterilization


[08800026103967]

Moist Heat or Steam Sterilization


[08800026103967]

Moist Heat or Steam Sterilization


[08800026103967]

Moist Heat or Steam Sterilization


[08800026103967]

Moist Heat or Steam Sterilization


[08800026103967]

Moist Heat or Steam Sterilization


[08800026103967]

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_Non hex Φ5.0]

08800026109464IUSB5064N
08800026109457IUSB5054N
08800026109440IUSB5044N
08800026109433IUSB5034N
08800026109426IUSB5024N
08800026109419IUSB5014N
08800026104056IUSB5067N
08800026104049IUSB5065N
08800026104032IUSB5057N
08800026104025IUSB5055N
08800026104018IUSB5047N
08800026104001IUSB5045N
08800026103998IUSB5037N
08800026103981IUSB5035N
08800026103974IUSB5027N
08800026103967IUSB5025N
08800026103950IUSB5017N
08800026103943IUSB5015N

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.