Prostate Caddy Rectal Balloon 3301

GUDID 00860005263103

Prostate Immobilization device. Rectal Balloon, single use, non-sterile. Box of 50.

Myriad Medical, LLC

Rectal probe Rectal probe Rectal probe Rectal probe Rectal probe Rectal probe Rectal probe Rectal probe Rectal probe Rectal probe Rectal probe Rectal probe Rectal probe Rectal probe

• Primary Device ID: 00860005263103
• NIH Device Record Key: 9158ba31-d538-4d44-96e9-314dda527fcc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prostate Caddy Rectal Balloon
• Version Model Number: 3301
• Catalog Number: 3301
• Company DUNS: 842448610
• Company Name: Myriad Medical, LLC
• Device Count: 50
• 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	00860005263103 [Unit of Use]
GS1	10860005263100 [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.