New Horizon Prone Breastboard MTHPBB100

GUDID 00841439104347

Cushion

MEDTEC, INC.

Radiological breast positioner, non-wearable

• Primary Device ID: 00841439104347
• NIH Device Record Key: 8dda9106-2097-4e6e-8883-dffef54c81f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: New Horizon Prone Breastboard
• Version Model Number: MTHPBB100
• Catalog Number: MTHPBB100
• 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

• Width: 9.1 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841439104347 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K974703

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: 5
• Public Version Date: 2019-05-30
• Device Publish Date: 2017-08-02

On-Brand Devices [New Horizon Prone Breastboard]

• 00841439104347: Cushion
• 00841439104330: Reusable non-sterile breastboard (148 x 55cm) with four spacers