FDA.reportPublic FDA data

Chabner XRT

Primary DI
00860012102389
Brand
Chabner XRT
Company
CHABNER XRT LLC
Model
CRTSHLDEXT
Catalog number
CRTSHLDEXT
Device description
"The Chabner XRT Bra Shoulder Extender ""the extender"" can only be used with the Chabner XRT Radiation Bra ""the bra"" to adjust and lengthen the shoulder straps of the bra for optimal fit and breast support during simulation, planning and radiation treatment, including proton therapy. The bra, with extender if needed, can also be used for breast support during other radiologic procedures such as CT, MRI and diagnostic X-rays. The bra, customizable for a wide variety of body types, is made of lightweight, advanced materials providing enhanced support ideal for positioning the breast and ensuring patient comfort without irritation or sensitization."
Published
2024-06-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYEAccelerator, Linear, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

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
00860012102389PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860012102389008600121023898600121023890860012102389

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9147138550inquiries@chabnerxrt.com

Regulatory Flags#

DUNS number
119156147
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860012102372Chabner XRTCRTEXTCRTEXT2024-06-28
00860011280101Chabner XRTCRTBRA01CRTBRA012024-01-03
00860011280118Chabner XRTCRTBRA02CRTBRA022024-01-03
00860011280125Chabner XRTCRTBRA03CRTBRA032024-01-03
00860011280132Chabner XRTCRTBRA04CRTBRA042024-01-03
00860011280149Chabner XRTCRTBRA05CRTBRA052024-01-03
00860011280156Chabner XRTCRTBRA06CRTBRA062024-01-03
00860011280163Chabner XRTCRTBRA07CRTBRA072024-01-03
00860011280170Chabner XRTCRTBRA08CRTBRA082024-01-03
00860011280187Chabner XRTCRTBRA09CRTBRA092024-01-03
00860011280194Chabner XRTCRTBRA10CRTBRA102024-01-03
00860011294900Chabner XRTCRTBRA11CRTBRA112024-01-03
00860011294917Chabner XRTCRTBRA12CRTBRA122024-01-03
00860011294924Chabner XRTCRTBRA13CRTBRA132024-01-03

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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