Surgical Screwdriver BIO-X1023

GUDID 07290119310562

BIOLINE DENTAL IMPLANT SYSTEMS LTD

Dental implant system
Primary Device ID07290119310562
NIH Device Record Keyd68940ac-680b-442d-b9fc-33f1ebf131ca
Commercial Distribution StatusIn Commercial Distribution
Brand NameSurgical Screwdriver
Version Model Number10mm Diameter x 144mm Length
Catalog NumberBIO-X1023
Company DUNS532209134
Company NameBIOLINE DENTAL IMPLANT SYSTEMS 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 Datefalse
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
GS107290119310562 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07290119310562]

Moist Heat or Steam Sterilization


[07290119310562]

Moist Heat or Steam Sterilization


[07290119310562]

Moist Heat or Steam Sterilization


[07290119310562]

Moist Heat or Steam Sterilization


[07290119310562]

Moist Heat or Steam Sterilization


[07290119310562]

Moist Heat or Steam Sterilization


[07290119310562]

Moist Heat or Steam Sterilization


[07290119310562]

Moist Heat or Steam Sterilization


[07290119310562]

Moist Heat or Steam Sterilization


[07290119310562]

Moist Heat or Steam Sterilization


[07290119310562]

Moist Heat or Steam Sterilization


[07290119310562]

Moist Heat or Steam Sterilization


[07290119310562]

Moist Heat or Steam Sterilization


[07290119310562]

Moist Heat or Steam Sterilization


[07290119310562]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-27
Device Publish Date2025-03-19

Devices Manufactured by BIOLINE DENTAL IMPLANT SYSTEMS LTD

07290119310609 - Driver Hex 1.25mm2025-03-31
07290119310616 - Driver Hex 1.25mm2025-03-31
07290119310623 - Driver Hex 1.25mm2025-03-31
07290119310630 - Driver Hex 2.42mm2025-03-31
07290119310647 - Driver Hex 2.42mm2025-03-31
07290119310654 - Driver Hex 2.42mm2025-03-31
07290119310661 - Slim Hex Driver 2.1mm2025-03-31
07290119310678 - Slim Hex Driver 2.1mm2025-03-31

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