Tru ASC Pro Kit

GUDID 08800076473263

Truabutment Korea Co.,Ltd

Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Primary Device ID08800076473263
NIH Device Record Key660e84c8-bef8-426f-a64d-d100cdef162f
Commercial Distribution StatusIn Commercial Distribution
Brand NameTru ASC Pro Kit
Version Model NumberTAPK01
Company DUNS694514760
Company NameTruabutment Korea Co.,Ltd
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800076473263 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800076473263]

Moist Heat or Steam Sterilization


[08800076473263]

Moist Heat or Steam Sterilization


[08800076473263]

Moist Heat or Steam Sterilization


[08800076473263]

Moist Heat or Steam Sterilization


[08800076473263]

Moist Heat or Steam Sterilization


[08800076473263]

Moist Heat or Steam Sterilization


[08800076473263]

Moist Heat or Steam Sterilization


[08800076473263]

Moist Heat or Steam Sterilization


[08800076473263]

Moist Heat or Steam Sterilization


[08800076473263]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-11
Device Publish Date2025-12-03

Devices Manufactured by Truabutment Korea Co.,Ltd

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08800076460935 - AOT Plus Impression Screw2025-12-11
08800076460942 - AOT Plus Impression Screw2025-12-11
08800076460959 - AOT Plus Impression Screw2025-12-11
08800076460966 - AOT Plus Impression Screw2025-12-11
08800076460973 - AOT Plus Impression Screw2025-12-11
08800076460980 - AOT Plus Impression Screw2025-12-11
08800076460997 - AOT Plus Impression Screw2025-12-11

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