Torque Ratchet BIO-X1021

GUDID 07290119310555

BIOLINE DENTAL IMPLANT SYSTEMS LTD

Dental implant system

• Primary Device ID: 07290119310555
• NIH Device Record Key: 3a216cec-7c6c-46cf-b69e-3f7347d72de7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Torque Ratchet
• Version Model Number: 98.4mm Length
• Catalog Number: BIO-X1021
• Company DUNS: 532209134
• Company Name: BIOLINE DENTAL IMPLANT SYSTEMS LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290119310555 [Primary]

FDA Product Code

• NDP: Accessories, Implant, Dental, Endosseous

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[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 Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-27
• Device Publish Date: 2025-03-19

Devices Manufactured by BIOLINE DENTAL IMPLANT SYSTEMS LTD

• 07290119310609 - Driver Hex 1.25mm: 2025-03-31
• 07290119310616 - Driver Hex 1.25mm: 2025-03-31
• 07290119310623 - Driver Hex 1.25mm: 2025-03-31
• 07290119310630 - Driver Hex 2.42mm: 2025-03-31
• 07290119310647 - Driver Hex 2.42mm: 2025-03-31
• 07290119310654 - Driver Hex 2.42mm: 2025-03-31
• 07290119310661 - Slim Hex Driver 2.1mm: 2025-03-31
• 07290119310678 - Slim Hex Driver 2.1mm: 2025-03-31