Machine Screw Driver,1.2 Hex, Long

GUDID 06947600316282

BIO CONCEPT Co., Ltd.

Surgical screwdriver, reusable
Primary Device ID06947600316282
NIH Device Record Key9858c360-d477-4053-908e-932917f42911
Commercial Distribution StatusIn Commercial Distribution
Brand NameMachine Screw Driver,1.2 Hex, Long
Version Model Number353250
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
GS106947600316282 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06947600316282]

Moist Heat or Steam Sterilization


[06947600316282]

Moist Heat or Steam Sterilization


[06947600316282]

Moist Heat or Steam Sterilization


[06947600316282]

Moist Heat or Steam Sterilization


[06947600316282]

Moist Heat or Steam Sterilization


[06947600316282]

Moist Heat or Steam Sterilization


[06947600316282]

Moist Heat or Steam Sterilization


[06947600316282]

Moist Heat or Steam Sterilization


[06947600316282]

Moist Heat or Steam Sterilization


[06947600316282]

Moist Heat or Steam Sterilization


[06947600316282]

Moist Heat or Steam Sterilization


[06947600316282]

Moist Heat or Steam Sterilization


[06947600316282]

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

Devices Manufactured by BIO CONCEPT Co., Ltd.

06936616987739 - Dome Drill,Φ5.5mm, L25mm2025-04-02
06936616987746 - Dome Drill,Φ7.0mm, L25mm2025-04-02
06936616987753 - Dome Drill,Φ7.0mm, L26mm2025-04-02
06936616987760 - Osteotome maxillary sinus elevation Drill,Φ2.8mm, L31mm2025-04-02
06936616987777 - Osteotome maxillary sinus elevation Drill,Φ2.8mm, L37mm2025-04-02
06936616987784 - Osteotome maxillary sinus elevation Drill,Φ3.1mm, L31mm2025-04-02
06936616987791 - Osteotome maxillary sinus elevation Drill,Φ3.1mm, L37mm2025-04-02
06936616987807 - Osteotome maxillary sinus elevation Drill,Φ3.3mm, L31mm2025-04-02

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