Reverse Drill

GUDID 08809917144751

Osstem Implant Co., Ltd.

Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use
Primary Device ID08809917144751
NIH Device Record Key83f05fb8-4b9e-43a3-a9af-02072401bedf
Commercial Distribution StatusIn Commercial Distribution
Brand NameReverse Drill
Version Model NumberHARVDRLC
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 Usetrue
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
GS108809917144751 [Primary]

FDA Product Code

DZADrill, Dental, Intraoral

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08809917144751]

Moist Heat or Steam Sterilization


[08809917144751]

Moist Heat or Steam Sterilization


[08809917144751]

Moist Heat or Steam Sterilization


[08809917144751]

Moist Heat or Steam Sterilization


[08809917144751]

Moist Heat or Steam Sterilization


[08809917144751]

Moist Heat or Steam Sterilization


[08809917144751]

Moist Heat or Steam Sterilization


[08809917144751]

Moist Heat or Steam Sterilization


[08809917144751]

Moist Heat or Steam Sterilization


[08809917144751]

Moist Heat or Steam Sterilization


[08809917144751]

Moist Heat or Steam Sterilization


[08809917144751]

Moist Heat or Steam Sterilization


[08809917144751]

Moist Heat or Steam Sterilization


[08809917144751]

Moist Heat or Steam Sterilization


[08809917144751]

Moist Heat or Steam Sterilization


[08809917144751]

Moist Heat or Steam Sterilization


[08809917144751]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-08
Device Publish Date2024-06-30

On-Brand Devices [Reverse Drill]

08809917144683ARVDRSC
08809917144676ARVDRLC
08809917144652ARVDMLC
08809917144768HARVDRSC
08809917144751HARVDRLC
08809917144744HARVDMLC

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