Solstat™ Immobilization System CHS06

GUDID 00841439112519

Head support system for use with Type-S™ systems

MEDTEC, INC.

Radiological headrest

• Primary Device ID: 00841439112519
• NIH Device Record Key: 8603ebb0-b676-4a20-8788-2e1bb7d6ddb7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solstat™ Immobilization System
• Version Model Number: CHS06
• Catalog Number: CHS06
• Company DUNS: 103977526
• Company Name: MEDTEC, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• 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: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com

Device Dimensions

• Width: 10.35 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841439112519 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182079

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: 2019-05-30
• Device Publish Date: 2019-01-07

On-Brand Devices [Solstat™ Immobilization System]

• 00841439112519: Head support system for use with Type-S™ systems
• 00841439112502: Head support system for use with Posifix® systems
• 00841439113448: Solstat™ Immobilization System