Bottom Stop 106029

GUDID 00841439100295

Reusable non-sterile bottom stop for use with Posiboard™

MEDTEC, INC.

Radiological breast positioner, non-wearable

• Primary Device ID: 00841439100295
• NIH Device Record Key: 250f7b2a-96d6-4991-9125-4093216c7acd
• Commercial Distribution Discontinuation: 2019-10-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Bottom Stop
• Version Model Number: 106029
• Catalog Number: 106029
• 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: 40 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841439100295 [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: 7
• Public Version Date: 2019-10-31
• Device Publish Date: 2017-08-02

Devices Manufactured by MEDTEC, INC.

• 00841439114667 - GE MR Posifix® Baseplate: 2024-10-09 Acrylic Baseplate
• 00841439114759 - Rectangular Extension: 2024-10-09 For use with Universal Couchtop™ Long Extension
• 00841439114612 - Wedge: 2024-07-17 5 degree wedge, MR
• 00841439114629 - Spacer: 2024-07-17 20mm spacer, MR
• 00841439114636 - Spacer: 2024-07-17 30mm spacer, MR
• 00841439114643 - Wedge and Spacer Set: 2024-07-17 2.5 degree wedge, 5 degree wedge, 20mm spacer, and 30mm spacer, MR
• 10841439114589 - BrachyGel Vaginal Hydrogel Packing System: 2024-05-31 BrachyGel Vaginal Hydrogel Packing System (BVHPS)
• 00841439114599 - Pro Posifix® Headrest Adapter: 2024-05-24 Pro Posifix® Headrest Adapter