FDA.report

CARDINAL HEALTH

Primary DI
10885380183263
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SB-XLG
Catalog number
SB-XLG
Device description
Surgical Bra Therapeutic Breast Support Xlarge
Published
2021-11-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HEFBINDER, BREAST

Product Code Classifications

CodeDeviceSpecialtyClass
HEFBinder, BreastGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10885380183263PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088538018326310885380183263

GMDN Terms

TermDefinition
Postsurgical brassiere, non-antimicrobialA woman's undergarment designed to support and/or contour the breast(s) after surgical intervention (e.g., thoracic surgery, mastectomy, lumpectomy); it may also be intended for use during medical treatment (e.g., chemotherapy). It may also be referred to as bra, and is specifically designed for patient support/comfort in the home or healthcare facility; it does not include antimicrobial features. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
50198956219043CARDINAL HEALTHSBA29BRCCFSBA29BRCCF2026-03-24
50198956219401CARDINAL HEALTHSOT29UR87ESOT29UR87E2026-03-24
50198956220513CARDINAL HEALTHSOT29CPCCDSOT29CPCCD2026-03-24
50198956220643CARDINAL HEALTHSCV29MN87ESCV29MN87E2026-03-24
50198956278484CARDINAL HEALTHSOPCNPPRVCSOPCNPPRVC2026-03-24
50198956284980CARDINAL HEALTH34-8041H34-8041H2026-03-24
50198956285987CARDINAL HEALTHSBACNLSMBGSBACNLSMBG2026-03-24
50198956300116CARDINAL HEALTH17C4553C17C4553C2026-03-24
50198956300499CARDINAL HEALTHSAN12BSSUJSAN12BSSUJ2026-03-24
50198956302929CARDINAL HEALTHSOP32SHFLKSOP32SHFLK2026-03-24
50198956306866CARDINAL HEALTHSBAOCBLCPCSBAOCBLCPC2026-03-24
50198956307986CARDINAL HEALTHSOP21EPSCGSOP21EPSCG2026-03-24
50198956308006CARDINAL HEALTHSOP21KPSCJSOP21KPSCJ2026-03-24
50198956311372CARDINAL HEALTHPVCGCGAUFPVCGCGAUF2026-03-24
50198956314687CARDINAL HEALTHSMAHDGVAAGSMAHDGVAAG2026-03-24
50198956322897CARDINAL HEALTHSEN1DNSUNNSEN1DNSUNN2026-03-24
50198956327939CARDINAL HEALTHSBACGMPACFSBACGMPACF2026-03-24
50198956328851CARDINAL HEALTHSANCGRPILCSANCGRPILC2026-03-24
50198956334760CARDINAL HEALTHSBACGHERIFSBACGHERIF2026-03-24
50198956335569CARDINAL HEALTHSNE19NSKHRSNE19NSKHR2026-03-24

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00817612021091Dale Post Surgical Compression BraDale Medical Products, Inc.HEF2025-03-31
50653160038311CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHEF2022-01-01
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00082161080084NuRooBROWNMED, INC.HEF2020-08-13
00849174080001NuRooBROWNMED, INC.HEF2020-08-13
00849174080308NuRooBROWNMED, INC.HEF2020-08-13
H84107021Dale Post Surgical BraDALE MEDICAL PRODUCTS, INC.HEF2018-08-27
H84107031Dale Post Surgical BraDALE MEDICAL PRODUCTS, INC.HEF2018-08-27
H84107041Dale Post Surgical BraDALE MEDICAL PRODUCTS, INC.HEF2018-08-27
H84107051Dale Post Surgical BraDALE MEDICAL PRODUCTS, INC.HEF2018-08-27
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