TotalRT All In One Platform TRT100

GUDID 00841439113875

Positioning and Immobilization System

MEDTEC, INC.

Radiological breast positioner, non-wearable
Primary Device ID00841439113875
NIH Device Record Keyad4f032c-c7ff-4586-be10-555f3b9c2c13
Commercial Distribution StatusIn Commercial Distribution
Brand NameTotalRT All In One Platform
Version Model NumberTRT100
Catalog NumberTRT100
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 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
Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com
Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841439113875 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LNHSystem, nuclear magnetic resonance imaging

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-23
Device Publish Date2022-05-13

Devices Manufactured by MEDTEC, INC.

00841439114612 - Wedge2024-07-17 5 degree wedge, MR
00841439114629 - Spacer2024-07-17 20mm spacer, MR
00841439114636 - Spacer2024-07-17 30mm spacer, MR
00841439114643 - Wedge and Spacer Set2024-07-17 2.5 degree wedge, 5 degree wedge, 20mm spacer, and 30mm spacer, MR
10841439114589 - BrachyGel Vaginal Hydrogel Packing System2024-05-31 BrachyGel Vaginal Hydrogel Packing System (BVHPS)
00841439114599 - Pro Posifix® Headrest Adapter2024-05-24 Pro Posifix® Headrest Adapter
10841439113650 - ProForm™ Thermoplastic2024-02-20 IMRT style 18 thermoplastic (3.2mm)
10841439113667 - ProForm™ Thermoplastic2024-02-20 IMRT FreedomView thermoplastic (3.2mm)

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