Trephine Bur

GUDID 08800041043378

Surgident Co.,Ltd.

Bone-coring punch, reusable
Primary Device ID08800041043378
NIH Device Record Keya2eb4d71-015a-4114-88a5-1ba5a7b2a5da
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrephine Bur
Version Model NumberESTB 35
Company DUNS689846448
Company NameSurgident Co.,Ltd.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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
GS108800041043378 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800041043378]

Moist Heat or Steam Sterilization


[08800041043378]

Moist Heat or Steam Sterilization


[08800041043378]

Moist Heat or Steam Sterilization


[08800041043378]

Moist Heat or Steam Sterilization


[08800041043378]

Moist Heat or Steam Sterilization


[08800041043378]

Moist Heat or Steam Sterilization


[08800041043378]

Moist Heat or Steam Sterilization


[08800041043378]

Moist Heat or Steam Sterilization


[08800041043378]

Moist Heat or Steam Sterilization


[08800041043378]

Moist Heat or Steam Sterilization


[08800041043378]

Moist Heat or Steam Sterilization


[08800041043378]

Moist Heat or Steam Sterilization


[08800041043378]

Moist Heat or Steam Sterilization


[08800041043378]

Moist Heat or Steam Sterilization


[08800041043378]

Moist Heat or Steam Sterilization


[08800041043378]

Moist Heat or Steam Sterilization


[08800041043378]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-02-27
Device Publish Date2023-02-17

On-Brand Devices [Trephine Bur]

08800041043392ESTB 45
08800041043385ESTB 40
08800041043378ESTB 35
08800041043361ESTB 30

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