Torque Ratchet BIO-X1021

GUDID 07290119310555

BIOLINE DENTAL IMPLANT SYSTEMS LTD

Dental implant system
Primary Device ID07290119310555
NIH Device Record Key3a216cec-7c6c-46cf-b69e-3f7347d72de7
Commercial Distribution StatusIn Commercial Distribution
Brand NameTorque Ratchet
Version Model Number98.4mm Length
Catalog NumberBIO-X1021
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
GS107290119310555 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07290119310555]

Moist Heat or Steam Sterilization


[07290119310555]

Moist Heat or Steam Sterilization


[07290119310555]

Moist Heat or Steam Sterilization


[07290119310555]

Moist Heat or Steam Sterilization


[07290119310555]

Moist Heat or Steam Sterilization


[07290119310555]

Moist Heat or Steam Sterilization


[07290119310555]

Moist Heat or Steam Sterilization


[07290119310555]

Moist Heat or Steam Sterilization


[07290119310555]

Moist Heat or Steam Sterilization


[07290119310555]

Moist Heat or Steam Sterilization


[07290119310555]

Moist Heat or Steam Sterilization


[07290119310555]

Moist Heat or Steam Sterilization


[07290119310555]

Moist Heat or Steam Sterilization


[07290119310555]

Moist Heat or Steam Sterilization


[07290119310555]

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

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