Sabella Flex SBS14-K

GUDID 10628341930267

SaBella Flex Dual Axis Precision Positioning Overlay Only (MR Conditional)

CDR Systems Inc

Indexed-immobilization patient positioning system

• Primary Device ID: 10628341930267
• NIH Device Record Key: f4169250-11e2-433b-8f92-25507f99d5a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sabella Flex
• Version Model Number: 1
• Catalog Number: SBS14-K
• Company DUNS: 206950904
• Company Name: CDR Systems Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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	00628341930260 [Primary]
GS1	10628341930267 [Package]; Contains: 00628341930260; 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 [Sabella Flex]

• 10628341930267: SaBella Flex Dual Axis Precision Positioning Overlay Only (MR Conditional)
• 10628341930250: SaBella Flex Dual Axis Precision Positioning Overlay Only