Posifix® Headrest 301027A

GUDID 00841439110386

Reusable non-sterile Prone headrest (extra small)

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 Radiological headrest Radiological headrest

• Primary Device ID: 00841439110386
• NIH Device Record Key: ee504bd8-3cd1-47bc-a3ec-43858527f0c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Posifix® Headrest
• Version Model Number: 301027A
• Catalog Number: 301027A
• 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
• 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
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841439110386 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060737

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: 4
• Public Version Date: 2019-05-31
• Device Publish Date: 2017-08-02

On-Brand Devices [Posifix® Headrest]

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