Bra Extender CRTEXT01

GUDID 00841439111673

Bra Extender

MEDTEC, INC.

Radiological breast positioner, wearable
Primary Device ID00841439111673
NIH Device Record Key00e82692-99f9-4558-844b-a7bc3b46d909
Commercial Distribution StatusIn Commercial Distribution
Brand NameBra Extender
Version Model NumberCRTEXT01
Catalog NumberCRTEXT01
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 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
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
Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com
Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com

Device Dimensions

Length7.75 Inch
Length7.75 Inch
Length7.75 Inch
Length7.75 Inch
Length7.75 Inch
Length7.75 Inch
Length7.75 Inch
Length7.75 Inch
Length7.75 Inch
Length7.75 Inch
Length7.75 Inch
Length7.75 Inch
Length7.75 Inch
Length7.75 Inch
Length7.75 Inch
Length7.75 Inch
Length7.75 Inch
Length7.75 Inch
Length7.75 Inch
Length7.75 Inch
Length7.75 Inch
Length7.75 Inch
Length7.75 Inch
Length7.75 Inch
Length7.75 Inch
Length7.75 Inch
Length7.75 Inch
Length7.75 Inch
Length7.75 Inch
Length7.75 Inch
Length7.75 Inch
Length7.75 Inch
Length7.75 Inch
Length7.75 Inch
Length7.75 Inch
Length7.75 Inch
Length7.75 Inch
Length7.75 Inch
Length7.75 Inch
Length7.75 Inch
Length7.75 Inch
Length7.75 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100841439111673 [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 Number6
Public Version Date2019-05-27
Device Publish Date2017-11-30

Devices Manufactured by MEDTEC, INC.

00841439115039 - Posi Indexing Bar2025-01-10 For use with MTM3303, MTM3304, MTM3305, MTM3004
00841439114858 - Headrest - TIMO Size A, B, C, D, E, F2024-12-12 (19.8 x 12.2 x 6.4cm) size A; (22.6 x 11.9 x 6.4cm) size B; (23.1 x 11.7 x 7.4cm) size C; (23.4 x 12.4 x 8.9cm) size D; (21.8 x
00841439114865 - Headrest - Timo Size A2024-12-12 (19.8 x 12.2 x 6.4cm)
00841439114872 - Headrest - Timo size B2024-12-12 (22.6 x 11.9 x 6.4cm)
00841439114889 - Headrest - Timo size C2024-12-12 (23.1 x 11.7 x 7.4cm)
00841439114896 - Headrest - Timo size D2024-12-12 (23.4 x 12.4 x 8.9cm)
00841439114902 - Headrest - Timo size E2024-12-12 (21.8 x 12.2 x 10.2cm)
00841439114919 - Headrest - Timo Size F2024-12-12 (23.4 x 12.2 x 9.1cm)

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