Solstice™ MR SRS Immobilization System CHS03MR

GUDID 00841439113233

Head support system for use with Posifix® systems

MEDTEC, INC.

Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest

• Primary Device ID: 00841439113233
• NIH Device Record Key: 31b3e851-37a1-46a7-8cdb-5196bc5b7a3e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solstice™ MR SRS Immobilization System
• Version Model Number: CHS03MR
• Catalog Number: CHS03MR
• 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
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841439113233 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182079

FDA Product Code

• LNH: System, nuclear magnetic resonance imaging

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: 2020-07-20
• Device Publish Date: 2020-07-10

On-Brand Devices [Solstice™ MR SRS Immobilization System]

• 00841439113240: Head support system for use with Type-S™ systems
• 00841439113233: Head support system for use with Posifix® systems
• 00841439113714: Solstice™ MR SRS Immobilization System