Tibial Cutting Jig

GUDID 00854515008385

Unique Surgical

Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable

• Primary Device ID: 00854515008385
• NIH Device Record Key: 5c92f133-b549-4c7a-a744-38d3238cdcdb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tibial Cutting Jig
• Version Model Number: 0 Degree, Right
• Company DUNS: 079820535
• Company Name: Unique Surgical
• 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: false
• 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: 818-813-8527
• Email: info@UniqueSurgical.com
• Phone: 818-813-8527
• Email: info@UniqueSurgical.com
• Phone: 818-813-8527
• Email: info@UniqueSurgical.com
• Phone: 818-813-8527
• Email: info@UniqueSurgical.com
• Phone: 818-813-8527
• Email: info@UniqueSurgical.com
• Phone: 818-813-8527
• Email: info@UniqueSurgical.com
• Phone: 818-813-8527
• Email: info@UniqueSurgical.com
• Phone: 818-813-8527
• Email: info@UniqueSurgical.com
• Phone: 818-813-8527
• Email: info@UniqueSurgical.com
• Phone: 818-813-8527
• Email: info@UniqueSurgical.com
• Phone: 818-813-8527
• Email: info@UniqueSurgical.com
• Phone: 818-813-8527
• Email: info@UniqueSurgical.com
• Phone: 818-813-8527
• Email: info@UniqueSurgical.com
• Phone: 818-813-8527
• Email: info@UniqueSurgical.com
• Phone: 818-813-8527
• Email: info@UniqueSurgical.com
• Phone: 818-813-8527
• Email: info@UniqueSurgical.com
• Phone: 818-813-8527
• Email: info@UniqueSurgical.com
• Phone: 818-813-8527
• Email: info@UniqueSurgical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854515008385 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00854515008385]

Moist Heat or Steam Sterilization

[00854515008385]

Moist Heat or Steam Sterilization

[00854515008385]

Moist Heat or Steam Sterilization

[00854515008385]

Moist Heat or Steam Sterilization

[00854515008385]

Moist Heat or Steam Sterilization

[00854515008385]

Moist Heat or Steam Sterilization

[00854515008385]

Moist Heat or Steam Sterilization

[00854515008385]

Moist Heat or Steam Sterilization

[00854515008385]

Moist Heat or Steam Sterilization

[00854515008385]

Moist Heat or Steam Sterilization

[00854515008385]

Moist Heat or Steam Sterilization

[00854515008385]

Moist Heat or Steam Sterilization

[00854515008385]

Moist Heat or Steam Sterilization

[00854515008385]

Moist Heat or Steam Sterilization

[00854515008385]

Moist Heat or Steam Sterilization

[00854515008385]

Moist Heat or Steam Sterilization

[00854515008385]

Moist Heat or Steam Sterilization

[00854515008385]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-06-30
• Device Publish Date: 2023-01-06

Devices Manufactured by Unique Surgical

• 00854515008385 - Tibial Cutting Jig: 2023-06-30
• 00854515008385 - Tibial Cutting Jig: 2023-06-30
• 00854515008323 - Patella Clamp: 2023-05-03
• 00854515008361 - Alignment Guide: 2023-05-03
• 00854515008101 - Lima Femoral Cutting Block: 2023-01-13
• 00854515008132 - Lima Femoral Cutting Block: 2023-01-13
• 00854515008149 - IM Rod: 2023-01-13
• 00854515008156 - T-Handle: 2023-01-13
• 00854515008231 - Angled Drill Bit: 2023-01-13