Freedom SB02-S1

GUDID 10628341930182

Freedom 6 Couch Extension Cranial

CDR Systems Inc

Indexed-immobilization patient positioning system

• Primary Device ID: 10628341930182
• NIH Device Record Key: 59d7367a-a1df-4bcd-ba5a-89da666ee37c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Freedom
• Version Model Number: 1
• Catalog Number: SB02-S1
• 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	00628341930185 [Primary]
GS1	10628341930182 [Package]; Contains: 00628341930185; 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 [Freedom]

• 10628341930366: PLUS Intuition Adapter Plate (MR Conditional)
• 10628341930359: PLUS Intuition Adapter Plate
• 10628341930342: Freedom Prone Head & Neck Immobilization
• 10628341930335: Freedom Hand Indexer for Linac Couches
• 10628341930212: Compression Belt
• 10628341930205: Roll Adapter
• 10628341930199: Freedom 6 Couch Extension, S-Type
• 10628341930182: Freedom 6 Couch Extension Cranial
• 10628341930175: Freedom 6 Couch Extension Head & Neck
• 00628341930109: Freedom Comprehensive CT/Treatment Overlay Gen-X (MR Conditional)
• 00628341930093: Freedom Comprehensive CT/Treatment Overlay Gen-X
• 00628341930086: Freedom Basic CT/Treatment Overlay (MR Conditional)
• 00628341930079: Freedom Basic CT/Treatment Overlay
• 00628341930062: Freedom Comprehensive CT/Treatment Overlay (MR Conditional)
• 00628341930055: Freedom Comprehensive CT/Treatment Overlay
• 10628341930427: Freedom Prone Head & Neck Immobilization (MR Conditional)
• 10628341930458: Freedom S-Type Overlay (MR Safe)
• 10628341930441: Freedom S-Type Overlay