Headrest MT250SUB5

GUDID 00841439102527

Reusable non-sterile (16 x 15.2 x 5.8cm) gel headrest

MEDTEC, INC.

Radiological breast positioner, non-wearable

• Primary Device ID: 00841439102527
• NIH Device Record Key: 95dd680e-09ff-492a-a135-0f9a55dd1380
• Commercial Distribution Discontinuation: 2017-08-02
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Headrest
• Version Model Number: MT250SUB5
• Catalog Number: MT250SUB5
• 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: false
• 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: 6.27 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841439102527 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K935411

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: 2019-03-11
• Device Publish Date: 2017-08-02

On-Brand Devices [Headrest]

• 00841439107683: (27.9 x 16.8 x 6.9cm) size A trimmed
• 00841439108017: Reusable non-sterile (24x12.6x6.4cm) size A; (24x12.6x6.4cm) size B; (24x12.6x7.4cm) size C; (24
• 00841439108000: (23.4 x 12.2 x 9.1cm)
• 00841439107997: (23.8 x 12 x 9.1cm)
• 00841439107980: (23.4 x 12.2 x 9.1cm)
• 00841439107973: (21.8 x 12.2 x 10.2cm)
• 00841439107966: (23.8 x 12 x 10.2cm)
• 00841439107959: (21.8 x 12.2 x 10.2cm)
• 00841439107942: (23.4 x 12.4 x 8.9cm)
• 00841439107935: (23.8 x 12 x 8.9cm)
• 00841439107928: (23.4 x 12.4 x 8.9cm)
• 00841439107911: (23.1 x 11.7 x 7.4cm)
• 00841439107904: (23.1 x 11.7 x 7.4cm)
• 00841439107898: (22.6 x 11.9 x 6.4)
• 00841439107881: (23.8 x 12 x 6.4cm)
• 00841439107874: (22.6 x 11.9 x 6.4cm)
• 00841439107867: (19.8 x 12.2 x 6.4cm)
• 00841439107850: (19.8 x 12.2 x 6.4cm)
• 00841439107843: Reusable non-sterile (19.8 x 12.2 x 6.4cm) size A; (22.6 x 11.9 x 6.4cm) size B;(23.1 x 11.7 x 7
• 00841439107737: (27.9 x 16.8 x 9.6cm) size F trimmed
• 00841439107720: (27.9 x 16.8 x 10.8cm) size E trimmed
• 00841439107713: (27.9 x 16.8 x 9.2cm) size D trimmed
• 00841439107706: (27.9 x 16.8 x 7.7cm) size C untrimmed
• 00841439107690: (27.9 x 16.8 x 6.8cm) size B trimmed
• 00841439107676: size A (27.9x16.8x6.9cm); size B (27.9x16.8x6.8cm); size C (27.9x16.8x7.7cm); size D (27.9x16.8x
• 00841439106532: Lateral head cushion (22.7 x 22.4 x 3.8cm)
• 00841439106525: Reusable non-sterile lateral head cushion (22.7 x 22.4 x 3.8cm)
• 00841439102503: (5.3 x 14.7 x 13.7cm)
• 00841439102497: (16 x 15.2 x 5.8cm)
• 00841439102527: Reusable non-sterile (16 x 15.2 x 5.8cm) gel headrest