ZENEX Guide Flattening Drill

GUDID 08800070234754

Izenimplant Co., Ltd.

Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Primary Device ID08800070234754
NIH Device Record Keyd84d5245-ab70-4ef8-93e3-8f74736e1d98
Commercial Distribution StatusIn Commercial Distribution
Brand NameZENEX Guide Flattening Drill
Version Model NumberZGFD4710R
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 Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800070234754 [Primary]

FDA Product Code

DZADrill, Dental, Intraoral

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800070234754]

Moist Heat or Steam Sterilization


[08800070234754]

Moist Heat or Steam Sterilization


[08800070234754]

Moist Heat or Steam Sterilization


[08800070234754]

Moist Heat or Steam Sterilization


[08800070234754]

Moist Heat or Steam Sterilization


[08800070234754]

Moist Heat or Steam Sterilization


[08800070234754]

Moist Heat or Steam Sterilization


[08800070234754]

Moist Heat or Steam Sterilization


[08800070234754]

Moist Heat or Steam Sterilization


[08800070234754]

Moist Heat or Steam Sterilization


[08800070234754]

Moist Heat or Steam Sterilization


[08800070234754]

Moist Heat or Steam Sterilization


[08800070234754]

Moist Heat or Steam Sterilization


[08800070234754]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-01-14
Device Publish Date2025-01-06

On-Brand Devices [ZENEX Guide Flattening Drill]

08800070231661ZGFD5209W
08800070231654ZGFD4612R
08800070231647ZGFD4610R
08800070231630ZGFD4609R
08800070231623ZGFD3712M
08800070234778ZGFD6309W
08800070234761ZGFD4712R
08800070234754ZGFD4710R
08800070234747ZGFD4709R
08800070230596ZGFD3512M

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