OneGuide KS Implant Driver

GUDID 08800271234003

Osstem Implant Co., Ltd.

Surgical screwdriver, reusable
Primary Device ID08800271234003
NIH Device Record Key51cdb27e-9a56-4bdc-8544-9fe8cbe93f6b
Commercial Distribution StatusIn Commercial Distribution
Brand NameOneGuide KS Implant Driver
Version Model NumberHOGIDHSR57K
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
GS108800271234003 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800271234003]

Moist Heat or Steam Sterilization


[08800271234003]

Moist Heat or Steam Sterilization


[08800271234003]

Moist Heat or Steam Sterilization


[08800271234003]

Moist Heat or Steam Sterilization


[08800271234003]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-17
Device Publish Date2024-12-09

On-Brand Devices [OneGuide KS Implant Driver]

08809917098719OGFDR57K
08809917098702OGFDR50K
08809917098696OGFDM50K
08809917098689OGFDM35K
08800271234003HOGIDHSR57K

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