Siemens Aera/skyra Upgrade Kit MTM3002U

GUDID 00841439110812

Reusable non-sterile lower table mount and body bridge clips (4)

MEDTEC, INC.

Indexed-immobilization patient positioning system
Primary Device ID00841439110812
NIH Device Record Keydf7c18a5-2aea-4ea6-97cd-de0abfb6c335
Commercial Distribution Discontinuation2019-05-31
Commercial Distribution StatusNot in Commercial Distribution
Brand NameSiemens Aera/skyra Upgrade Kit
Version Model NumberMTM3002U
Catalog NumberMTM3002U
Company DUNS103977526
Company NameMEDTEC, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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

Device Dimensions

Length53.5 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100841439110812 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYEAccelerator, linear, medical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-05-31
Device Publish Date2017-08-02

Devices Manufactured by MEDTEC, INC.

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10841439113674 - ProForm™ Thermoplastic2024-02-20 IMRT style 18 thermoplastic (3.2mm)
10841439113681 - ProForm™ Thermoplastic2024-02-20 IMRT Clear Vision 2 open face thermoplastic (3.2mm)
10841439113698 - ProForm™ Thermoplastic2024-02-20 IMRT FreedomView thermoplastic (3.2mm)
10841439113704 - ProForm™ Thermoplastic2024-02-20 IMRT Clear Vision 2 open face thermoplastic (3.2mm)
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00841439114513 - Mevion Rectangular Backrest2024-02-12 For use with Mevion S250-FIT Proton Therapy System™

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