Initial Drill

GUDID 08809917144324

Osstem Implant Co., Ltd.

Fixture/appliance dental drill bit, reusable
Primary Device ID08809917144324
NIH Device Record Key066da72b-8d18-4dbc-8f0d-b84b5e4a0980
Commercial Distribution StatusIn Commercial Distribution
Brand NameInitial Drill
Version Model NumberOGFD52EXWC
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
GS108809917144324 [Primary]

FDA Product Code

DZADrill, Dental, Intraoral

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08809917144324]

Moist Heat or Steam Sterilization


[08809917144324]

Moist Heat or Steam Sterilization


[08809917144324]

Moist Heat or Steam Sterilization


[08809917144324]

Moist Heat or Steam Sterilization


[08809917144324]

Moist Heat or Steam Sterilization


[08809917144324]

Moist Heat or Steam Sterilization


[08809917144324]

Moist Heat or Steam Sterilization


[08809917144324]

Moist Heat or Steam Sterilization


[08809917144324]

Moist Heat or Steam Sterilization


[08809917144324]

Moist Heat or Steam Sterilization


[08809917144324]

Moist Heat or Steam Sterilization


[08809917144324]

Moist Heat or Steam Sterilization


[08809917144324]

Moist Heat or Steam Sterilization


[08809917144324]

Moist Heat or Steam Sterilization


[08809917144324]

Moist Heat or Steam Sterilization


[08809917144324]

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 [Initial Drill]

08809917098740OGID2206IT
08809917098726OGID2206IIT
08809917070128HOGID2206IT
08809917070111HOGID2206IIT
08809917098771OGID2206IW
08809917098764OGID2206IWC
08809917098757OGID2206I
08809917098733OGID2206II
08809917098603OGD2206ISWC
08809917098597OGD2206IS
08809917098580OGD2206IIS
08809917144324OGFD52EXWC

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