OrthoSolutions 'System26' Bone Screws OS919000-NS

GUDID 05055662918359

8.0MM HEADED FLAT WASHER

ORTHO SOLUTIONS HOLDINGS LIMITED

Orthopaedic bone washer, non-sterile Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer

• Primary Device ID: 05055662918359
• NIH Device Record Key: 30a808a7-3198-4a36-bcd1-6cc7c0fc3dd2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OrthoSolutions 'System26' Bone Screws
• Version Model Number: OS919000-NS
• Catalog Number: OS919000-NS
• Company DUNS: 218648211
• Company Name: ORTHO SOLUTIONS HOLDINGS LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055662918359 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163489

FDA Product Code

• NDG: Washer, Bolt, Nut, Non-Spinal, Metallic

Sterilization

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

[05055662918359]

Moist Heat or Steam Sterilization

[05055662918359]

Moist Heat or Steam Sterilization

[05055662918359]

Moist Heat or Steam Sterilization

[05055662918359]

Moist Heat or Steam Sterilization

[05055662918359]

Moist Heat or Steam Sterilization

[05055662918359]

Moist Heat or Steam Sterilization

[05055662918359]

Moist Heat or Steam Sterilization

[05055662918359]

Moist Heat or Steam Sterilization

[05055662918359]

Moist Heat or Steam Sterilization

[05055662918359]

Moist Heat or Steam Sterilization

[05055662918359]

Moist Heat or Steam Sterilization

[05055662918359]

Moist Heat or Steam Sterilization

[05055662918359]

Moist Heat or Steam Sterilization

[05055662918359]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-03-22