Trephine Drill

GUDID 08800000952024

Osstem Implant Co., Ltd.

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Primary Device ID08800000952024
NIH Device Record Keya9937e18-095f-4ab4-bbc8-1758eb0dd0d0
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrephine Drill
Version Model NumberTD42S
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
GS108800000952024 [Primary]

FDA Product Code

DZADrill, Dental, Intraoral

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800000952024]

Moist Heat or Steam Sterilization


[08800000952024]

Moist Heat or Steam Sterilization


[08800000952024]

Moist Heat or Steam Sterilization


[08800000952024]

Moist Heat or Steam Sterilization


[08800000952024]

Moist Heat or Steam Sterilization


[08800000952024]

Moist Heat or Steam Sterilization


[08800000952024]

Moist Heat or Steam Sterilization


[08800000952024]

Moist Heat or Steam Sterilization


[08800000952024]

Moist Heat or Steam Sterilization


[08800000952024]

Moist Heat or Steam Sterilization


[08800000952024]

Moist Heat or Steam Sterilization


[08800000952024]

Moist Heat or Steam Sterilization


[08800000952024]

Moist Heat or Steam Sterilization


[08800000952024]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-04-03
Device Publish Date2022-12-08

On-Brand Devices [Trephine Drill]

08809917071408TD62
08809917071392TD62S
08809917071385TD57
08809917071378TD57S
08809917071361TD52
08809917071354TD52S
08809917071347TD47
08809917071330TD47S
08809917071323TD42
08809917071316TD42S
08809917071309TD37
08809917071293TD37S
08800209373088HTD62S
08800209373071HTD62
08800209373064HTD57S
08800209373057HTD57
08800209373040HTD52S
08800209373033HTD52
08800209373026HTD47S
08800209373019HTD47
08800209373002HTD42S
08800209372999HTD42
08800209372982HTD37S
08800209372975HTD37
08800040612414TD57
08800000961323TD57S
08800000952109TD62S
08800000952093TD62
08800000952079TD52S
08800000952062TD52
08800000952055TD47S
08800000952048TD47
08800000952024TD42S
08800000952017TD42
08800000951591TD37S
08800000951584TD37

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