FDA.reportPublic FDA data

HCS

Primary DI
10849027004151
Brand
HCS
Company
DYAD MEDICAL SOURCING, LLC
Model
HCS1504-100
Device description
Mesh Briefs, Disposable, XXXL w/Blue Band, Bulk 100
Published
2019-12-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
EYQGarment, Protective, For Incontinence

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EYQGarment, Protective, For IncontinenceGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10849027004151PrimaryGS10
20849027004158Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084902700415110849027004151
2084902700415820849027004158

GMDN Terms#

Term, Definition table
TermDefinition
Incontinence pants, single-useAn underwear designed to retain urine leakage in incontinent adults and older children. It typically consists of a single-use man?s brief or woman?s panty with external softness and shape resembling regular underwear, and an internal pad and/or isolated shell capable of retaining the urine of patients with light or medium incontinence while keeping the skin dry. The device is used in healthcare facilities or at home.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078572603
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10849027004694HCSHCS5025TS2020-11-16
00849027004703HCSHCS5035TS2020-11-16
10849027004717HCSHCS5045TS2020-11-16
10849027004724HCSHCS5065TS2020-11-16
10849027005103HCSHCS3013BK2021-10-19
10849027005134HCS3001BU2021-05-07
10849027005141HCS3001BXL2021-05-07
10849027004656HCSHCS5033-25S2021-01-31
10849027004663HCSHCS5033-35S2021-01-31
10849027004670HCSHCS5033-45S2021-01-31
10849027004687HCSHCS5033-65S2021-01-31
30849027004858HCSHCS02112021-01-31
30849027004865HCSHCS02122021-01-31
30849027004872HCSHCS02132021-01-31
30849027004889HCSHCS02142021-01-31
10849027004946HCSHCS1108HC2021-01-29
10849027005028HCSHCS5033-411LF2021-01-29
10849027005035HCSHCS5033-411S2021-01-31
10849027005042HCSHCS5033-611S2021-01-31
10849027005189HCSHCS11202021-01-31

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05703538498886AbenaAbena North America, IncEYQ2026-02-18
96979303250009CuteleafZhangzhou Win Share Co.,Ltd.EYQ2026-01-13
96979303250016CuteleafZhangzhou Win Share Co.,Ltd.EYQ2026-01-13
96979303250047CuteleafZhangzhou Win Share Co.,Ltd.EYQ2026-01-13
05703538474811AbenaAbena North America, IncEYQ2025-11-17
05703538474835AbenaAbena North America, IncEYQ2025-11-17
05703538474859AbenaAbena North America, IncEYQ2025-11-17
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