FDA.reportPublic FDA data

THERA Plus

Primary DI
00049696187879
Brand
THERA Plus
Company
FOURSTAR GROUP INC.
Model
64432156A
Device description
MEN'S UNDERWEAR 10CT_L-XL
Published
2023-10-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00049696187879PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00049696187879000496961878790496961878790049696187879

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
656091279
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00049696561228THERA Plus644103222026-06-09
00049696189583THERA Plus644101842026-06-09
00049696198189B.PURE644103382026-06-09
00049696295260THERA Plus644103662026-06-09
00049696295277THERA Plus644103662026-06-09
00049696295284THERA Plus644103662026-06-09
00049696295291THERA Plus644103662026-06-09
00049696295307THERA Plus644103662026-06-09
00049696295314THERA Plus644103662026-06-09
00049696508339THERA Plus64409658V2026-06-09
00049696508346B.PURE64409346B2026-06-09
00049696508360THERA Plus64409535A2026-06-09
00049696508377THERA Plus64409535B2026-06-09
00049696508384THERA Plus64409535C2026-06-09
00049696561518B.PURE644103252026-06-09
00049696562102B.PURE644103262026-06-09
00049696677547THERA Plus644103832026-06-09
00049696712194B.PURE644102892026-06-09
00049696898232B.PURE64410005D2026-06-09
00050428284537CVSHealth64408659Y2026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810065846433WeareverPRIME LIFE FIBERSEYQ2025-09-23
00810065846440WeareverPRIME LIFE FIBERSEYQ2025-09-23
00810065846457WeareverPRIME LIFE FIBERSEYQ2025-09-23
00810065846464WeareverPRIME LIFE FIBERSEYQ2025-09-23
00810065846471WeareverPRIME LIFE FIBERSEYQ2025-09-23
00810065846488WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010177WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010184WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010191WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010207WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010214WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010221WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010658WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010665WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010672WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010689WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010696WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010702WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010719WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010726WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010733WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010740WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877011501WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877011518WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877011525WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877011532WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877011549WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877011556WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877011563WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877011570WeareverPRIME LIFE FIBERSEYQ2025-09-23