Prone Breast PB17

GUDID 10628341930281

Procline

CDR Systems Inc

Indexed-immobilization patient positioning system

• Primary Device ID: 10628341930281
• NIH Device Record Key: 6157a2a6-6d50-4372-93c2-f48698e0c929
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prone Breast
• Version Model Number: 1
• Catalog Number: PB17
• Company DUNS: 206950904
• Company Name: CDR Systems Inc
• Device Count: 1
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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: 403-850-7035
• Email: info@cdrsys.ca

Device Identifiers

Device Issuing Agency	Device ID
GS1	00628341930284 [Primary]
GS1	10628341930281 [Package]; Contains: 00628341930284; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122888

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: 2020-01-08
• Device Publish Date: 2019-12-31

On-Brand Devices [Prone Breast]

• 10628341930298: Procline (MR Conditional)
• 10628341930281: Procline
• 10628341930274: Prone Breast Positioning