Inserter Coupling Screw 9mm & 10mm

GUDID 08437019739577

Instrument used to couple the cap of the WasherCap™ Fixation System to the inserter, threading it into the inserter until the “device-inserter” assembly is fully engaged.

ABANZA TECNOMED SL.

Orthopaedic implantation sleeve, reusable

• Primary Device ID: 08437019739577
• NIH Device Record Key: 8d7cb8ce-03f1-4e7d-8e98-9411fc2d5e2f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inserter Coupling Screw 9mm & 10mm
• Version Model Number: 21
• Company DUNS: 465714287
• Company Name: ABANZA TECNOMED SL.
• Device Count: 1
• DM Exempt: true
• 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: true
• 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

Customer Support Contacts

• Phone: (866) 550-7070
• Email: customerservice@abanzamed.com
• Phone: (866) 550-7070
• Email: customerservice@abanzamed.com
• Phone: (866) 550-7070
• Email: customerservice@abanzamed.com
• Phone: (866) 550-7070
• Email: customerservice@abanzamed.com
• Phone: (866) 550-7070
• Email: customerservice@abanzamed.com
• Phone: (866) 550-7070
• Email: customerservice@abanzamed.com
• Phone: (866) 550-7070
• Email: customerservice@abanzamed.com
• Phone: (866) 550-7070
• Email: customerservice@abanzamed.com
• Phone: (866) 550-7070
• Email: customerservice@abanzamed.com
• Phone: (866) 550-7070
• Email: customerservice@abanzamed.com
• Phone: (866) 550-7070
• Email: customerservice@abanzamed.com
• Phone: (866) 550-7070
• Email: customerservice@abanzamed.com
• Phone: (866) 550-7070
• Email: customerservice@abanzamed.com
• Phone: (866) 550-7070
• Email: customerservice@abanzamed.com
• Phone: (866) 550-7070
• Email: customerservice@abanzamed.com
• Phone: (866) 550-7070
• Email: customerservice@abanzamed.com
• Phone: (866) 550-7070
• Email: customerservice@abanzamed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08437019739577 [Primary]
GS1	28437019739571 [Package]; Package: Primary [1 Units]; In Commercial Distribution

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[08437019739577]

Moist Heat or Steam Sterilization

[08437019739577]

Moist Heat or Steam Sterilization

[08437019739577]

Moist Heat or Steam Sterilization

[08437019739577]

Moist Heat or Steam Sterilization

[08437019739577]

Moist Heat or Steam Sterilization

[08437019739577]

Moist Heat or Steam Sterilization

[08437019739577]

Moist Heat or Steam Sterilization

[08437019739577]

Moist Heat or Steam Sterilization

[08437019739577]

Moist Heat or Steam Sterilization

[08437019739577]

Moist Heat or Steam Sterilization

[08437019739577]

Moist Heat or Steam Sterilization

[08437019739577]

Moist Heat or Steam Sterilization

[08437019739577]

Moist Heat or Steam Sterilization

[08437019739577]

Moist Heat or Steam Sterilization

[08437019739577]

Moist Heat or Steam Sterilization

[08437019739577]

Moist Heat or Steam Sterilization

[08437019739577]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-09
• Device Publish Date: 2023-06-01

Devices Manufactured by ABANZA TECNOMED SL.

• 28437019739861 - WasherCap™ Fixation System 11mm: 2025-03-18 WasherCap™ Fixation System is a device which provides soft tissue graft fastening. It is intended for fixation of soft tissue
• 28437019739892 - WasherCap Mini Fixation system 3.5mm: 2025-03-05 The WasherCap™ Mini Fixation System is a medical device designed for fixation of suture/tape (soft tissue) to bone during surg
• 28437019739908 - WasherCap Mini Fixation system 4.5mm: 2025-03-05 The WasherCap™ Mini Fixation System is a medical device designed for fixation of suture/tape (soft tissue) to bone during surg
• 08437019739812 - WasherCap™ Fixation System 7mm: 2023-06-19 WasherCap™ Fixation System is a device which provides soft tissue graft fastening. It is intended for fixation of soft tissue
• 08437019739829 - WasherCap™ Fixation System 8mm: 2023-06-19 WasherCap™ Fixation System is a device which provides soft tissue graft fastening. It is intended for fixation of soft tissue
• 08437019739836 - WasherCap™ Fixation System 9mm: 2023-06-19 WasherCap™ Fixation System is a device which provides soft tissue graft fastening. It is intended for fixation of soft tissue
• 08437019739843 - WasherCap™ Fixation System 10mm: 2023-06-19 WasherCap™ Fixation System is a device which provides soft tissue graft fastening. It is intended for fixation of soft tissue
• 08437019739164 - WasherCap™ Screwdriver: 2023-06-09 Instrument used to screw the “screw-washer” assembly to the cap, locking the tendon against the locking corridor of the cap.