OSSIO® Staple Sizing Guide THN00292

GUDID 07290019361046

OSSIO® Staple Sizing Guide.

OSSIO LTD

Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable

• Primary Device ID: 07290019361046
• NIH Device Record Key: 0ea17685-f84f-446f-a5d7-5d458ad9c467
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSSIO® Staple Sizing Guide
• Version Model Number: THN00292
• Catalog Number: THN00292
• 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: false
• 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

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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290019361046 [Primary]

FDA Product Code

• HWT: Template

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: 2023-10-31
• Device Publish Date: 2023-10-23

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: 2023-10-31OSSIO® Staple Sizing Guide.
• 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.