Thermoplastic

GUDID 10628341930229

Thermoplastic Immobilization Materials

CDR Systems Inc

Patient positioning thermoplastic mould material

• Primary Device ID: 10628341930229
• NIH Device Record Key: 00c978da-2c1e-456d-a571-1ab9e0e5efe2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Thermoplastic
• Version Model Number: 1
• 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: true
• 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	00628341930222 [Primary]
GS1	10628341930229 [Package]; Contains: 00628341930222; Package: [5 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 [Thermoplastic]

• 10628341930229: Thermoplastic Immobilization Materials
• 10628341930380: Thermoplastic Immobilization Mask
• 10628341930373: Thermoplastic Immobilization Materials