FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10885380183256
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SB-SML
Catalog number
SB-SML
Device description
Surgical Bra Therapeutic Breast Support Small
Published
2021-11-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
OTC
true

Product Codes#

Code, Name table
CodeName
HEFBINDER, BREAST

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HEFBinder, BreastGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885380183256PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088538018325610885380183256

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10197106992753CARDINAL HEALTHSCV40VP52CSCV40VP52C2026-09-25
10198956169357CARDINAL HEALTHSCV69EVWKASCV69EVWKA2026-09-25
10198956172715CARDINAL HEALTHSBA21PPSCCSBA21PPSCC2026-09-25
10198956321335CARDINAL HEALTHPEHDTRVCKPEHDTRVCK2026-09-25
10198956339729CARDINAL HEALTHSBA22ATMRASBA22ATMRA2026-09-25
10198956374232CARDINAL HEALTHSOP41KASRBSOP41KASRB2026-09-25
10198956383043CARDINAL HEALTHORC3R7765BORC3R7765B2026-09-25
10198956388239CARDINAL HEALTHSOT53CYPOFSOT53CYPOF2026-09-25
10198956393288CARDINAL HEALTHSBA73GPMVBSBA73GPMVB2026-09-25
10198956400801CARDINAL HEALTHSOP3MHPCVCSOP3MHPCVC2026-09-25
10198956402522CARDINAL HEALTHSMA13GLEXDSMA13GLEXD2026-09-25
10198956424654CARDINAL HEALTHPO54TKCMDPO54TKCMD2026-09-25
10198956439849CARDINAL HEALTHSAN69PCKOGSAN69PCKOG2026-09-25
10198956444263CARDINAL HEALTHPV36HPCHEPV36HPCHE2026-09-25
10198956450684CARDINAL HEALTHSMA58CSLOPSMA58CSLOP2026-09-25
10198956461086CARDINAL HEALTHSBACGBPGSHSBACGBPGSH2026-09-25
10198956462205CARDINAL HEALTHPV08TCGHHPV08TCGHH2026-09-25
10198956466159CARDINAL HEALTH03-2656S03-2656S2026-09-25
10198956466838CARDINAL HEALTHSNE35LSFSGSNE35LSFSG2026-09-25
10198956484382CARDINAL HEALTHANE306276AANE306276A2026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817612021053Dale Post Surgical Compression BraDale Medical Products, Inc.HEF2025-03-31
00817612021060Dale Post Surgical Compression BraDale Medical Products, Inc.HEF2025-03-31
00817612021077Dale Post Surgical Compression BraDale Medical Products, Inc.HEF2025-03-31
00817612021084Dale Post Surgical Compression BraDale Medical Products, Inc.HEF2025-03-31
00817612021091Dale Post Surgical Compression BraDale Medical Products, Inc.HEF2025-03-31
00817612020964Dale Post Surgical BraDale Medical Products, Inc.HEF2024-04-25
00653160038316CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHEF2022-01-01
50653160038311CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHEF2022-01-01
10885380183201CARDINAL HEALTHCardinal Health 200, LLCHEF2021-11-12
10885380183218CARDINAL HEALTHCardinal Health 200, LLCHEF2021-11-12
10885380183225CARDINAL HEALTHCardinal Health 200, LLCHEF2021-11-12
10885380183232CARDINAL HEALTHCardinal Health 200, LLCHEF2021-11-12
10885380183249CARDINAL HEALTHCardinal Health 200, LLCHEF2021-11-12
10885380183263CARDINAL HEALTHCardinal Health 200, LLCHEF2021-11-12
10885380183270CARDINAL HEALTHCardinal Health 200, LLCHEF2021-11-12
10885380183287CARDINAL HEALTHCardinal Health 200, LLCHEF2021-11-12
10885380183294CARDINAL HEALTHCardinal Health 200, LLCHEF2021-11-12
10885380183317CARDINAL HEALTHCardinal Health 200, LLCHEF2021-11-12
10885380183324CARDINAL HEALTHCardinal Health 200, LLCHEF2021-11-12
10885380183331CARDINAL HEALTHCardinal Health 200, LLCHEF2021-11-12
00082161080053NuRooBROWNMED, INC.HEF2020-08-13
00082161080060NuRooBROWNMED, INC.HEF2020-08-13
00082161080077NuRooBROWNMED, INC.HEF2020-08-13
00082161080084NuRooBROWNMED, INC.HEF2020-08-13
00849174080001NuRooBROWNMED, INC.HEF2020-08-13
00849174080308NuRooBROWNMED, INC.HEF2020-08-13
00817612020452Dale Post Surgical BraDale Medical Products, Inc.HEF2019-06-24
00817612020469Dale Post Surgical BraDale Medical Products, Inc.HEF2019-06-24
00817612020476Dale Post Surgical BraDale Medical Products, Inc.HEF2019-06-24
00817612020483Dale Post Surgical BraDale Medical Products, Inc.HEF2019-06-24