Posifix® Headrest 301027

GUDID 00841439100974

Posifix® Headrest - Prone (Pediatric)

MEDTEC, INC.

Radiological headrest

• Primary Device ID: 00841439100974
• NIH Device Record Key: fb4eac4e-4732-44f8-a9f2-68ff296e13d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Posifix® Headrest
• Version Model Number: 301027
• Catalog Number: 301027
• 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: 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 Identifiers

Device Issuing Agency	Device ID
GS1	00841439100974 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060737

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: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-03-31
• Device Publish Date: 2017-08-02

On-Brand Devices [Posifix® Headrest]

• 00841439110386: Reusable non-sterile Prone headrest (extra small)
• 00841439109991: Posifix® Headrest - Prone
• 00841439102268: Set of five supine headrests
• 00841439101322: Reusable non-sterile set of five supine headrests
• 00841439101278: Set of three contoured headrests
• 00841439100974: Posifix® Headrest - Prone (Pediatric)
• 00841439100967: Posifix® Headrest - Supine (Pediatric)
• 00841439100950: Reusable non-sterile Posifix® Prone headrest