Mevion Rectangular Backrest MTIL7111

GUDID 00841439114513

For use with Mevion S250-FIT Proton Therapy System™

MEDTEC, INC.

Indexed-immobilization patient positioning system
Primary Device ID00841439114513
NIH Device Record Key95391429-b579-4125-9310-7979d5a17605
Commercial Distribution StatusIn Commercial Distribution
Brand NameMevion Rectangular Backrest
Version Model NumberMTIL7111
Catalog NumberMTIL7111
Company DUNS103977526
Company NameMEDTEC, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com
Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com
Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com
Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com
Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com
Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com
Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com
Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com
Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com
Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com
Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com
Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com
Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com
Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com
Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com
Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com
Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com
Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841439114513 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IXQTable, radiographic, stationary top

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-12
Device Publish Date2024-02-03

Devices Manufactured by MEDTEC, INC.

00841439114650 - Pronumbra2025-09-22 Pronumbra Helping Hand, Left
00841439114674 - Pronumbra2025-09-22 Pronumbra Helping Hand, Right
00841439114681 - Pronumbra2025-09-22 Pronumbra 130cm kVue
00841439114698 - Pronumbra2025-09-22 Pronumbra Neck Support, 40mm
00841439114704 - Pronumbra2025-09-22 Pronumbra Neck Support, 50mm
00841439114711 - Pronumbra2025-09-22 Pronumbra Neck Support, 65mm
00841439114728 - Pronumbra2025-09-22 Pronumbra Shoulder Adapter
00841439114841 - ZiFix Traverse2025-09-22 ZiFix Traverse with ONEClamp

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.