K-BALL 01BK0001

GUDID 03701313007942

K-BALL

S.M.A.I.O

CT phantom, test object

• Primary Device ID: 03701313007942
• NIH Device Record Key: 3349c2eb-f523-4389-8128-c241aecc48d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: K-BALL
• Version Model Number: 01BK0001
• Catalog Number: 01BK0001
• Company DUNS: 260585710
• Company Name: S.M.A.I.O
• 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: true
• Manufacturing Date: true
• Expiration Date: false
• 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: +33469842302
• Email: contact@smaio.com
• Phone: +33469842302
• Email: contact@smaio.com
• Phone: +33469842302
• Email: contact@smaio.com
• Phone: +33469842302
• Email: contact@smaio.com
• Phone: +33469842302
• Email: contact@smaio.com
• Phone: +33469842302
• Email: contact@smaio.com
• Phone: +33469842302
• Email: contact@smaio.com
• Phone: +33469842302
• Email: contact@smaio.com
• Phone: +33469842302
• Email: contact@smaio.com
• Phone: +33469842302
• Email: contact@smaio.com
• Phone: +33469842302
• Email: contact@smaio.com
• Phone: +33469842302
• Email: contact@smaio.com
• Phone: +33469842302
• Email: contact@smaio.com
• Phone: +33469842302
• Email: contact@smaio.com
• Phone: +33469842302
• Email: contact@smaio.com
• Phone: +33469842302
• Email: contact@smaio.com
• Phone: +33469842302
• Email: contact@smaio.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03701313007942 [Primary]

FDA Product Code

• JAC: System, X-Ray, Film Marking, Radiographic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-01
• Device Publish Date: 2023-12-22

Devices Manufactured by S.M.A.I.O

• 03701313008024 - KHEIRON: 2025-04-16
• 03701313009366 - KHEIRON: 2025-03-24 Large Hudson pedicle screwdriver
• 03701313001001 - KHEIRON: 2024-07-02 Ø6.5 L65mm pedicle screw
• 03701313001094 - KHEIRON: 2024-07-02 Ø7.5 L65mm pedicle screw
• 03701313001100 - KHEIRON: 2024-07-02 Ø7.5 L70mm pedicle screw
• 03701313001117 - KHEIRON: 2024-07-02 Ø7.5 L80mm pedicle screw
• 03701313001124 - KHEIRON: 2024-07-02 Ø7.5 L90mm pedicle screw
• 03701313001131 - KHEIRON: 2024-07-02 Ø7.5 L100mm pedicle screw