FDA.report

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
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
10885380183256PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088538018325610885380183256

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

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10192253013016Argyle888875001888887500182022-10-26
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10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
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