Trephine Drill

GUDID 06947600319795

BIO CONCEPT Co., Ltd.

Bone trephine, reusable
Primary Device ID06947600319795
NIH Device Record Keycc48ffa9-babc-4c93-a515-48a8d5fd5902
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrephine Drill
Version Model Number352420
Company DUNS527603266
Company NameBIO CONCEPT 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
GS106947600319795 [Primary]

FDA Product Code

DZADrill, Dental, Intraoral

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06947600319795]

Moist Heat or Steam Sterilization


[06947600319795]

Moist Heat or Steam Sterilization


[06947600319795]

Moist Heat or Steam Sterilization


[06947600319795]

Moist Heat or Steam Sterilization


[06947600319795]

Moist Heat or Steam Sterilization


[06947600319795]

Moist Heat or Steam Sterilization


[06947600319795]

Moist Heat or Steam Sterilization


[06947600319795]

Moist Heat or Steam Sterilization


[06947600319795]

Moist Heat or Steam Sterilization


[06947600319795]

Moist Heat or Steam Sterilization


[06947600319795]

Moist Heat or Steam Sterilization


[06947600319795]

Moist Heat or Steam Sterilization


[06947600319795]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-02
Device Publish Date2025-03-25

On-Brand Devices [Trephine Drill]

06947600319856352480
06947600319849352470
06947600319832352460
06947600319825352450
06947600319818352440
06947600319801352430
06947600319795352420
06947600319788352410
06947600319771352400
06947600319764352390
06947600319757352380
06947600316626352490

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.