Osteotome

GUDID 08800041053223

Surgident Co.,Ltd.

Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable
Primary Device ID08800041053223
NIH Device Record Key12889840-2652-4605-b776-b75ff99e328c
Commercial Distribution StatusIn Commercial Distribution
Brand NameOsteotome
Version Model NumberOST-8
Company DUNS689846448
Company NameSurgident Co.,Ltd.
Device Count1
DM Exempttrue
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
GS108800041053223 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800041053223]

Moist Heat or Steam Sterilization


[08800041053223]

Moist Heat or Steam Sterilization


[08800041053223]

Moist Heat or Steam Sterilization


[08800041053223]

Moist Heat or Steam Sterilization


[08800041053223]

Moist Heat or Steam Sterilization


[08800041053223]

Moist Heat or Steam Sterilization


[08800041053223]

Moist Heat or Steam Sterilization


[08800041053223]

Moist Heat or Steam Sterilization


[08800041053223]

Moist Heat or Steam Sterilization


[08800041053223]

Moist Heat or Steam Sterilization


[08800041053223]

Moist Heat or Steam Sterilization


[08800041053223]

Moist Heat or Steam Sterilization


[08800041053223]

Moist Heat or Steam Sterilization


[08800041053223]

Moist Heat or Steam Sterilization


[08800041053223]

Moist Heat or Steam Sterilization


[08800041053223]

Moist Heat or Steam Sterilization


[08800041053223]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-13
Device Publish Date2023-03-03

On-Brand Devices [Osteotome]

08800041053223OST-8
08800041038411R-4.0
08800041038404R-3.5
08800041038398R-3.0
08800041038381R-2.5
08800041038374R-2.0
08800041038367S-4.0
08800041038350S-3.5
08800041038343S-3.0
08800041038336S-2.5
08800041038329S-2.0

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