Bite Impression Coping Driver

GUDID 08800070235065

Izenimplant Co., Ltd.

Surgical screwdriver, reusable
Primary Device ID08800070235065
NIH Device Record Key5b9ca6d0-f58d-46bf-bd52-fafba0f08620
Commercial Distribution StatusIn Commercial Distribution
Brand NameBite Impression Coping Driver
Version Model NumberBICD5014S
Company DUNS963328442
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
GS108800070235065 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800070235065]

Moist Heat or Steam Sterilization


[08800070235065]

Moist Heat or Steam Sterilization


[08800070235065]

Moist Heat or Steam Sterilization


[08800070235065]

Moist Heat or Steam Sterilization


[08800070235065]

Moist Heat or Steam Sterilization


[08800070235065]

Moist Heat or Steam Sterilization


[08800070235065]

Moist Heat or Steam Sterilization


[08800070235065]

Moist Heat or Steam Sterilization


[08800070235065]

Moist Heat or Steam Sterilization


[08800070235065]

Moist Heat or Steam Sterilization


[08800070235065]

Moist Heat or Steam Sterilization


[08800070235065]

Moist Heat or Steam Sterilization


[08800070235065]

Moist Heat or Steam Sterilization


[08800070235065]

Moist Heat or Steam Sterilization


[08800070235065]

Moist Heat or Steam Sterilization


[08800070235065]

Moist Heat or Steam Sterilization


[08800070235065]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-09-23
Device Publish Date2024-09-13

On-Brand Devices [Bite Impression Coping Driver]

08800070235065BICD5014S
08800070235003BICD5018L
08800070234945BICD4014S
08800070234877BICD4018L
08800070236864BICD50LS
08800070236857BICD50SS
08800070236840BICD40LS
08800070236833BICD40SS

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