Flattening Drill

GUDID 08809917098634

Osstem Implant Co., Ltd.

Fixture/appliance dental drill bit, reusable
Primary Device ID08809917098634
NIH Device Record Key5f556ea7-4bd7-4a4a-b728-565be2b2fa90
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlattening Drill
Version Model NumberOGFD30
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
GS108809917098634 [Primary]

FDA Product Code

DZADrill, Dental, Intraoral

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08809917098634]

Moist Heat or Steam Sterilization


[08809917098634]

Moist Heat or Steam Sterilization


[08809917098634]

Moist Heat or Steam Sterilization


[08809917098634]

Moist Heat or Steam Sterilization


[08809917098634]

Moist Heat or Steam Sterilization


[08809917098634]

Moist Heat or Steam Sterilization


[08809917098634]

Moist Heat or Steam Sterilization


[08809917098634]

Moist Heat or Steam Sterilization


[08809917098634]

Moist Heat or Steam Sterilization


[08809917098634]

Moist Heat or Steam Sterilization


[08809917098634]

Moist Heat or Steam Sterilization


[08809917098634]

Moist Heat or Steam Sterilization


[08809917098634]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-09
Device Publish Date2023-11-01

On-Brand Devices [Flattening Drill]

08809917098641OGFD45T
08809917098627OGFD30T
08809917070104HOGFD45T
08809917070098HOGFD30T
08809917098672OGFD52W
08809917098665OGFD52WC
08809917098658OGFD45
08809917098634OGFD30
08800271234058HOGFD52EXWC

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