Pelvis Belly Replacement Stomach Cushion - Small PPRT-5108

GUDID 00714646001511

Pelvis Belly Replacement Stomach Cushion - Small

Bionix, LLC

Radiological whole-body positioner

• Primary Device ID: 00714646001511
• NIH Device Record Key: a7bcc5ab-6257-47c6-b6da-562d7ae89452
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pelvis Belly Replacement Stomach Cushion - Small
• Version Model Number: PPRT-5108
• Catalog Number: PPRT-5108
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00714646001511 [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: 2025-08-29
• Device Publish Date: 2025-08-21

Devices Manufactured by Bionix, LLC

• 00714646001474 - Pelvis Belly Replacement Leg Cushion: 2025-08-29 Pelvis Belly Replacement Leg Cushion
• 00714646001481 - Pelvis Belly Replacement Arm Rest Cushion: 2025-08-29 Pelvis Belly Replacement Arm Rest Cushion
• 00714646001498 - Pelvis Belly Replacement Stomach Cushion - Medium: 2025-08-29 Pelvis Belly Replacement Stomach Cushion - Medium
• 00714646001504 - Pelvis Belly Replacement Face Cushion Assembly: 2025-08-29 Pelvis Belly Replacement Face Cushion Assembly
• 00714646001511 - Pelvis Belly Replacement Stomach Cushion - Small: 2025-08-29Pelvis Belly Replacement Stomach Cushion - Small
• 00714646001511 - Pelvis Belly Replacement Stomach Cushion - Small: 2025-08-29 Pelvis Belly Replacement Stomach Cushion - Small
• 10714646001099 - Microsuction Stater Pack: 2025-07-16 Microsuction Starter Pack
• 10714646001105 - Microsuction Replacement Pack: 2025-07-16 Microsuction Replacement Pack
• 10714646001129 - Sample: Opti-Tatt: 2025-06-30 Opti-Tatt Sample - 2 Dot, 2 Crosshair, 2 Field Border