ORTHO SOLUTIONS STERILE DRILL BITSORTHO SOLUTIONS OSS-8351

GUDID 05055662942262

SAGITTAL BLADE 90.0MM X 25.4MM X 1.20MM

ORTHO SOLUTIONS HOLDINGS LIMITED

Oscillating surgical saw blade, single-use

• Primary Device ID: 05055662942262
• NIH Device Record Key: 6104189a-243f-4764-b698-4131a2642031
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORTHO SOLUTIONS STERILE DRILL BITSORTHO SOLUTIONS
• Version Model Number: OSS-8351
• Catalog Number: OSS-8351
• 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: true
• 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
• 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
• 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	05055662942262 [Package]; Contains: 05055662942279; Package: Cardboard Box [5 Units]; In Commercial Distribution
GS1	05055662942279 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102743

FDA Product Code

• HWE: Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-23

Devices Manufactured by ORTHO SOLUTIONS HOLDINGS LIMITED

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• 05055662969665 - COGNiTiON™ Staple System: 2024-04-09 COGNiTiON 2 LEG STAPLE 15MM X 15MM
• 05055662969672 - COGNiTiON™ Staple System: 2024-04-09 COGNiTiON 2 LEG STAPLE 20MM X 15MM
• 05055662969689 - COGNiTiON™ Staple System: 2024-04-09 COGNiTiON 2 LEG STAPLE 20MM X 20MM
• 05055662969696 - COGNiTiON™ Staple System: 2024-04-09 COGNiTiON 2 LEG STAPLE 25MM X 20MM
• 05055662969702 - COGNiTiON™ Staple System: 2024-04-09 COGNiTiON 4 LEG STAPLE 20MM X 15MM
• 05055662969719 - COGNiTiON™ Staple System: 2024-04-09 COGNiTiON 4 LEG STAPLE 20MM X 20MM
• 05055662969726 - COGNiTiON™ Staple System: 2024-04-09 COGNiTiON 4 LEG STAPLE 25MM X 20MM