Prone Breast, Face Cushion, Replacement PBRT-6253

GUDID 00714646001399

Prone Breast, Face Cushion, Replacement

Bionix, LLC

Radiological whole-body positioner

• Primary Device ID: 00714646001399
• NIH Device Record Key: fa66288f-e157-4ad1-9ffb-6d168f7c2093
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prone Breast, Face Cushion, Replacement
• Version Model Number: PBRT-6253
• Catalog Number: PBRT-6253
• Company DUNS: 117844489
• Company Name: Bionix, LLC
• Device Count: 1
• DM Exempt: true
• 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: false
• Lot Batch: true
• Serial Number: false
• 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: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00714646001399 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040773

FDA Product Code

• IYE: Accelerator, linear, medical

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: 2025-06-05
• Device Publish Date: 2025-05-28

Devices Manufactured by Bionix, LLC

• 00714646001382 - Prone Breast, Cushion, Contralateral Breast Insert, 15 degree, Replacement: 2025-06-05 Prone Breast, Cushion, Contralateral Breast Insert, 15 degree, Replacement
• 00714646001399 - Prone Breast, Face Cushion, Replacement: 2025-06-05Prone Breast, Face Cushion, Replacement
• 00714646001399 - Prone Breast, Face Cushion, Replacement: 2025-06-05 Prone Breast, Face Cushion, Replacement
• 00714646001405 - Prone Breast, Arm Rest, Replacement: 2025-06-05 Prone Breast, Arm Rest, Replacement
• 00714646001412 - Prone Breast, Leg Cushion, Replacement: 2025-06-05 Prone Breast, Leg Cushion, Replacement
• 00714646001429 - Prone Breast, Hand Post Assembly, Replacement: 2025-06-05 Prone Breast, Hand Post Assembly, Replacement
• 00714646001436 - Prone Breast, Hardware Kit, Threaded Indexing Pegs: 2025-06-05 Prone Breast, Hardware Kit, Threaded Indexing Pegs
• 00714646001443 - Prone Breast, Hardware Kit, Head Rest Push Button Assembly Replacement: 2025-06-05 Prone Breast, Hardware Kit, Head Rest Push Button Assembly, Replacement
• 00714646001450 - Prone Breast, Hardware Kit, Head Rest Carriage, Replacement: 2025-06-05 Prone Breast, Hardware Kit, Head Rest Carriage, Replacement