OneGuide TS NoMount Driver

GUDID 08800271234027

Osstem Implant Co., Ltd.

Surgical screwdriver, reusable
Primary Device ID08800271234027
NIH Device Record Keyfc91db7f-17fc-4ed2-b561-6b09720ef4f0
Commercial Distribution StatusIn Commercial Distribution
Brand NameOneGuide TS NoMount Driver
Version Model NumberHOGNMDR57I
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
GS108800271234027 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800271234027]

Moist Heat or Steam Sterilization


[08800271234027]

Moist Heat or Steam Sterilization


[08800271234027]

Moist Heat or Steam Sterilization


[08800271234027]

Moist Heat or Steam Sterilization


[08800271234027]

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 TS NoMount Driver]

08809917109255OGNMDR50
08809917108654OGNMDM50
08809917108487OGNMDR57
08800271234027HOGNMDR57I
08800271234010HOGNMDM57

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