Prone Face Cushion MTPFC01

GUDID 00841439106983

Reusable non-sterile (26.6 x 13.2 x 5cm) cushion

MEDTEC, INC.

Radiological headrest

• Primary Device ID: 00841439106983
• NIH Device Record Key: 77e293af-9385-4c23-9b3c-39f167a7f947
• Commercial Distribution Discontinuation: 2020-01-16
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Prone Face Cushion
• Version Model Number: MTPFC01
• Catalog Number: MTPFC01
• Company DUNS: 103977526
• Company Name: MEDTEC, INC.
• Device Count: 1
• DM Exempt: true
• 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: false
• Lot Batch: true
• Serial Number: false
• 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

• Length: 9.5 Inch

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841439106983 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K973842

FDA Product Code

• IXQ: Table, radiographic, stationary top

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-01-16
• Device Publish Date: 2017-08-02

On-Brand Devices [Prone Face Cushion]

• 00841439106990: Reusable non-sterile (26.2 x 13.2 x 5cm) cushion
• 00841439106983: Reusable non-sterile (26.6 x 13.2 x 5cm) cushion