FDA.reportPublic FDA data

Chabner XRT Radiation Bra

Primary DI
00841439111604
Brand
Chabner XRT Radiation Bra
Company
MEDTEC, INC.
Model
CRTBRA03
Catalog number
CRTBRA03
Device description
Chabner XRT Radiation Bra
Published
2017-11-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYEAccelerator, linear, medical
LNHSystem, nuclear magnetic resonance imaging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2
LNHSystem, Nuclear Magnetic Resonance ImagingRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121284000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121284000CHABNER XRT GARMENTSChabner Xrt, LLC2013-06-14IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841439111604PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841439111604008414391116048414391116040841439111604

GMDN Terms#

Term, Definition table
TermDefinition
Radiological breast positioner, wearableA garment designed to be worn by a female patient to support/position the breast(s) and chest during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures. The device is typically in the form of a brassiere.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Circumference31.5Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(712)737-8688radiotherapy.complaints@civcort.com

Regulatory Flags#

DUNS number
103977526
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841439114391AccuForm™ CushionMTACLTYPESNMTACLTYPESN2023-03-11
00841439113844Vac-Lok™ CushionVLPLV10CVLPLV10C2022-03-24
00841439109755Fiducial Marker KitMTNW887851MTNW8878512017-08-02
00841439109779Fiducial Marker KitMTNW887853MTNW8878532017-08-02
00841439109793Fiducial MarkersMTNW887855MTNW8878552017-08-02
00841439103029AccuForm™ CushionMTACL14242MTACL142422017-08-02
00841439103036AccuForm™ CushionMTACL1520MTACL15202017-08-02
00841439103081AccuForm™ CushionMTACL6060MTACL60602017-08-02
00841439103098AccuForm™ CushionMTACLTYPES1MTACLTYPES12017-08-02
00841439107591Lok-Bar™MTSBRT264MTSBRT2642017-08-02
00841439115152Upright Arm PositionerRT-4900RT-49002026-01-08
00841439113059Registration FilmPRO340PRO3402019-10-10
00841439114032Pediatric Registration FilmPRO440PRO4402022-08-20
00841439113240Solstice™ MR SRS Immobilization SystemCHS04MRCHS04MR2020-07-10
00841439110904RediFoam™MTFA41BMTFA41B2017-08-02
00841439110911RediFoam™MTFA40BMTFA40B2017-08-02
00841439110928RediFoam™MTFA39BMTFA39B2017-08-02
00841439101056Low Kneefix™ 23010483010482017-08-02
00841439101070Kneefix™ 33010523010522017-08-02
00841439101124Feetfix™ 33010713010712017-08-02

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816396022676WGS-100 Respiration PillowIVY BIOMEDICAL SYSTEMS, INC.LNH2026-08-03
00816396023550WGS-100 Wireless Gating SystemIVY BIOMEDICAL SYSTEMS, INC.LNH2026-08-03
00816396023567WGS-100 TransmitterIVY BIOMEDICAL SYSTEMS, INC.LNH2026-08-03
00816396023574WGS-100 Base StationIVY BIOMEDICAL SYSTEMS, INC.LNH2026-08-03
00840510401450KLARITY MEDICALKlarity Medical Products, LLCIYE2026-08-03
07090042059091nordicAktivaNordicneurolab ASLNH2026-08-03
05056190501211AlignRT PlusVISION RT LIMITEDIYE2026-07-30
00840510401443KLARITY MEDICALKlarity Medical Products, LLCIYE2026-07-24
00866463000496STAGESpintech, Inc.LNH2026-07-23
00840510401436KLARITY MEDICALKlarity Medical Products, LLCIYE2026-07-22
00840510401412KLARITY MEDICALKlarity Medical Products, LLCIYE2026-07-08
00840510401429KLARITY MEDICALKlarity Medical Products, LLCIYE2026-07-08
04068151086584LungMapsSiemens Healthineers AGLNH2026-06-24
00840510401382KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-23
00840510401399KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-23
00840510401405KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-23
00840510401375KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-22
00840510401368KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-09
00840510401351KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-08
00841962120500Single Hand Extremity FibreplastQfixIYE2026-06-05
00841962120517Knee / Elbow Extremity FibreplastQfixIYE2026-06-05
00841962120524Foot Extremity FibreplastQfixIYE2026-06-05
00841962120531Dual Hand / Shoulder Extremity FibreplastQfixIYE2026-06-05
00841439115305MultiFix 2QfixIYE2026-06-04
00841439115312MultiFix 2 - JointGlowQfixIYE2026-06-04
00841439115329Extremity RiserQfixIYE2026-06-04
00841439115336Extremity Riser - JointGlowQfixIYE2026-06-04
00841439115343MultiFix Indexing PostQfixIYE2026-06-04
00840510401320KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-03
00840510401344KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-03