K-BALL 01BK0001

GUDID 03701313007942

K-BALL

S.M.A.I.O

CT phantom, test object CT phantom, test object CT phantom, test object CT phantom, test object CT phantom, test object CT phantom, test object CT phantom, test object CT phantom, test object CT phantom, test object CT phantom, test object CT phantom, test object CT phantom, test object CT phantom, test object CT phantom, test object CT phantom, test object CT phantom, test object 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

• 03701313001490 - KHEIRON: 2024-04-10 Post Nut Driver
• 03701313007942 - K-BALL: 2024-01-01K-BALL
• 03701313007942 - K-BALL: 2024-01-01 K-BALL
• 03701313007935 - KHEIRON: 2023-08-01 Spinal surgery planning software
• 03701313000479 - KHEIRON: 2023-06-13 Spinal surgery planning software
• 03701313005030 - KHEIRON: 2023-05-17 Ø6.0 Ti patient specific K-ROD rod
• 03701313005047 - KHEIRON: 2023-05-17 Ø5.5 Ti patient specific K-ROD rod
• 03701313000394 - KHEIRON: 2022-02-08 Counterhook counter torque
• 03701313000400 - KHEIRON: 2022-02-08 Iliac extension holder