Driver Hex 2.42mm BIO-X2410

GUDID 07290119310647

BIOLINE DENTAL IMPLANT SYSTEMS LTD

Dental implant system
Primary Device ID07290119310647
NIH Device Record Keyc1b9ee8e-873b-4a7a-9255-9e85078ac015
Commercial Distribution StatusIn Commercial Distribution
Brand NameDriver Hex 2.42mm
Version Model Number8mm Diameter x 20.2mm Length
Catalog NumberBIO-X2410
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
GS107290119310647 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07290119310647]

Moist Heat or Steam Sterilization


[07290119310647]

Moist Heat or Steam Sterilization


[07290119310647]

Moist Heat or Steam Sterilization


[07290119310647]

Moist Heat or Steam Sterilization


[07290119310647]

Moist Heat or Steam Sterilization


[07290119310647]

Moist Heat or Steam Sterilization


[07290119310647]

Moist Heat or Steam Sterilization


[07290119310647]

Moist Heat or Steam Sterilization


[07290119310647]

Moist Heat or Steam Sterilization


[07290119310647]

Moist Heat or Steam Sterilization


[07290119310647]

Moist Heat or Steam Sterilization


[07290119310647]

Moist Heat or Steam Sterilization


[07290119310647]

Moist Heat or Steam Sterilization


[07290119310647]

Moist Heat or Steam Sterilization


[07290119310647]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-31
Device Publish Date2025-03-21

On-Brand Devices [Driver Hex 2.42mm]

072901193106548mm Diameter x 25.2mm Length
072901193106478mm Diameter x 20.2mm Length
072901193106308mm Diameter x 17.2mm Length

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