OSSIO® Compression Screw Instruments For 3.5 mm Screws THN00132

GUDID 07290017630915

OSSIO® Compression Screw Instruments For 3.5 mm Screws. Package contains: 1 Instrument Pack.

OSSIO LTD

Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use

• Primary Device ID: 07290017630915
• NIH Device Record Key: 1004c0e5-9755-4b98-b363-72660736e8aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSSIO® Compression Screw Instruments For 3.5 mm Screws
• Version Model Number: THN00132
• Catalog Number: THN00132
• Company DUNS: 600505107
• Company Name: OSSIO 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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: 1-833-781-7373
• Email: customer_service@ossio.io
• Phone: 1-833-781-7373
• Email: customer_service@ossio.io
• Phone: 1-833-781-7373
• Email: customer_service@ossio.io
• Phone: 1-833-781-7373
• Email: customer_service@ossio.io
• Phone: 1-833-781-7373
• Email: customer_service@ossio.io
• Phone: 1-833-781-7373
• Email: customer_service@ossio.io
• Phone: 1-833-781-7373
• Email: customer_service@ossio.io
• Phone: 1-833-781-7373
• Email: customer_service@ossio.io
• Phone: 1-833-781-7373
• Email: customer_service@ossio.io
• Phone: 1-833-781-7373
• Email: customer_service@ossio.io
• Phone: 1-833-781-7373
• Email: customer_service@ossio.io
• Phone: 1-833-781-7373
• Email: customer_service@ossio.io
• Phone: 1-833-781-7373
• Email: customer_service@ossio.io
• Phone: 1-833-781-7373
• Email: customer_service@ossio.io
• Phone: 1-833-781-7373
• Email: customer_service@ossio.io
• Phone: 1-833-781-7373
• Email: customer_service@ossio.io

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290017630915 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-22
• Device Publish Date: 2022-09-14

Devices Manufactured by OSSIO LTD

• 07290019361060 - OSSIOfiber® Trimmable Fixation Nail, Cannulated: 2024-02-02 OSSIOfiber® Trimmable Fixation Nail, 4.0x100mm, Cannulated. Package contains: 1 Implant.
• 07290019361046 - OSSIO® Staple Sizing Guide: 2023-10-31 OSSIO® Staple Sizing Guide.
• 07290017630946 - OSSIOfiber® Suture Anchor: 2023-09-22 OSSIOfiber® Suture Anchor 5.5 mm with Suture Snare. Package contains: 1 Implant,1 Inserter,1 Suture Snare.
• 07290017630953 - OSSIO® Drill Bit & Drill Guide Pack: 2023-09-22 OSSIO® Drill Bit & Drill Guide Pack, For 5.5 mm Suture Anchor. Package contains: 1 Instrument Pack.
• 07290017630960 - OSSIO® Punch Pack: 2023-09-22 OSSIO® Punch Pack, For 5.5 mm Suture Anchor.
• 07290017630984 - OSSIO® Tap Pack: 2023-09-22 OSSIO® Tap Pack, For 5.5 mm Suture Anchor.
• 07290019361053 - OSSIO® Drill Bit 2.5 mm For Staple: 2023-08-03 OSSIO® Drill Bit 2.5 mm For Staple
• 07290017630977 - OSSIO® Tap Pack: 2023-05-31 OSSIO® Tap Pack, For 4.75 mm Suture Anchor.