Prostate Caddy Rectal Balloon 9901

GUDID 00860005263127

Prostate Immobilization device. Rectal Balloon with inflation syringe, single use, non-sterile. Box of 25.

Myriad Medical, LLC

Rectal probe

• Primary Device ID: 00860005263127
• NIH Device Record Key: bbc7bf0d-32df-49d0-9350-160de74fda84
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prostate Caddy Rectal Balloon
• Version Model Number: 9901
• Catalog Number: 9901
• Company DUNS: 842448610
• Company Name: Myriad Medical, LLC
• Device Count: 25
• DM Exempt: false
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860005263127 [Unit of Use]
GS1	10860005263124 [Primary]

FDA Product Code

• PCT: Prostate Immobilizer Rectal Balloon

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: 2020-10-01
• Device Publish Date: 2020-09-23

On-Brand Devices [Prostate Caddy Rectal Balloon]

• 00860005263127: Prostate Immobilization device. Rectal Balloon with inflation syringe, single use, non-sterile.
• 00860005263110: Prostate Immobilization device. Rectal Balloon and inflation syringe, single use, non-sterile.
• 00860005263103: Prostate Immobilization device. Rectal Balloon, single use, non-sterile. Box of 50.