OneGuide TS Implant Driver

GUDID 08800271234201

Osstem Implant Co., Ltd.

Surgical screwdriver, reusable
Primary Device ID08800271234201
NIH Device Record Key05d7a6ce-d7be-47cc-b4fc-3c478b1acc6d
Commercial Distribution StatusIn Commercial Distribution
Brand NameOneGuide TS Implant Driver
Version Model NumberOGIDHSM57
Company DUNS689051793
Company NameOsstem Implant 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 Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800271234201 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800271234201]

Moist Heat or Steam Sterilization


[08800271234201]

Moist Heat or Steam Sterilization


[08800271234201]

Moist Heat or Steam Sterilization


[08800271234201]

Moist Heat or Steam Sterilization


[08800271234201]

Moist Heat or Steam Sterilization


[08800271234201]

Moist Heat or Steam Sterilization


[08800271234201]

Moist Heat or Steam Sterilization


[08800271234201]

Moist Heat or Steam Sterilization


[08800271234201]

Moist Heat or Steam Sterilization


[08800271234201]

Moist Heat or Steam Sterilization


[08800271234201]

Moist Heat or Steam Sterilization


[08800271234201]

Moist Heat or Steam Sterilization


[08800271234201]

Moist Heat or Steam Sterilization


[08800271234201]

Moist Heat or Steam Sterilization


[08800271234201]

Moist Heat or Steam Sterilization


[08800271234201]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-01-13
Device Publish Date2025-01-03

On-Brand Devices [OneGuide TS Implant Driver]

08809917109170OGFDR57
08809917109163OGFDR50
08809917109125OGFDM50
08800271233990HOGIDHSR57
08800271233983HOGIDHSM57
08800271234218OGIDHSR57
08800271234201OGIDHSM57

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