Instaform IFF03

GUDID 10628341930328

Instaform Kit

CDR Systems Inc

Patient positioning foam mould kit

• Primary Device ID: 10628341930328
• NIH Device Record Key: 32666661-0faa-460e-9517-a11996e9c999
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Instaform
• Version Model Number: 1
• Catalog Number: IFF03
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00628341930321 [Primary]
GS1	10628341930328 [Package]; Contains: 00628341930321; Package: [4 Units]; In Commercial Distribution
GS1	20628341930325 [Package]; Contains: 00628341930321; Package: [6 Units]; In Commercial Distribution
GS1	30628341930322 [Package]; Contains: 00628341930321; Package: [8 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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-01-16
• Device Publish Date: 2019-12-31

Devices Manufactured by CDR Systems Inc

• 10628341930502 - EQUILIBRIUM: 2024-02-02 EQUILIBRIUM Rotating Overlay System
• 10628341930373 - Thermoplastic: 2024-01-08 Thermoplastic Immobilization Materials
• 10628341930380 - Thermoplastic: 2024-01-08 Thermoplastic Immobilization Mask
• 10628341930465 - TBI: 2023-03-16 TBI Positioning System With Spoiler
• 10628341930441 - Freedom: 2023-03-03 Freedom S-Type Overlay
• 10628341930458 - Freedom: 2023-03-03 Freedom S-Type Overlay (MR Safe)
• 00628341930406 - Solid Bolus: 2020-05-25 Solid Bolus
• 10628341930427 - Freedom: 2020-05-25 Freedom Prone Head & Neck Immobilization (MR Conditional)