Twist Drill

GUDID 08800070237144

Izenimplant Co., Ltd.

Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Primary Device ID08800070237144
NIH Device Record Key3bcb7e43-9a33-45aa-946e-ece421e5351e
Commercial Distribution StatusIn Commercial Distribution
Brand NameTwist Drill
Version Model NumberTDM2F30L
Company DUNS694625347
Company NameIzenimplant 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 Numberfalse
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
GS108800070237144 [Primary]

FDA Product Code

DZADrill, Dental, Intraoral

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800070237144]

Moist Heat or Steam Sterilization


[08800070237144]

Moist Heat or Steam Sterilization


[08800070237144]

Moist Heat or Steam Sterilization


[08800070237144]

Moist Heat or Steam Sterilization


[08800070237144]

Moist Heat or Steam Sterilization


[08800070237144]

Moist Heat or Steam Sterilization


[08800070237144]

Moist Heat or Steam Sterilization


[08800070237144]

Moist Heat or Steam Sterilization


[08800070237144]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-03
Device Publish Date2025-06-25

On-Brand Devices [Twist Drill]

08800070225011TD2F46L
08800070225004TD2F46S
08800070224991TD2F41L
08800070224984TD2F41S
08800070224977TD2F36L
08800070224960TD2F36S
08800070224953TD2F30L
08800070224946TD2F30S
08800070224939TD2F27L
08800070224922TD2F27S
08800070224915TD2F25L
08800070224908TD2F25S
08800070224892TD2F22L
08800070224885TD2F22S
08800070237144TDM2F30L
08800070237137TDM2F27L
08800070237120TDM2F25L
08800070237113TDM2F22L

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