Identity
- Trade Name
- THERA Plus FDA UDI
- Generic Name
- Incontinence pants, single-use FDA UDI
- Device Name
- WOMEN'S UNDERWEAR 10CT_L-XL FDA UDI
- Model / Reference
- 64432152A FDA UDI
- Description
- WOMEN'S UNDERWEAR 10CT_L-XL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00049696187886 FDA UDI
- FDA Product Code
- EYQ FDA UDI
- GMDN Term
- Incontinence pants, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.5920 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Incontinence pants, single-use
THERA Plus by Fourstar Group Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Incontinence pants, single-use.
- Wings — Cardinalhealth · Class I
- FLUFSAN — EUROPROSAN SPA · Class I
- Wings — Cardinalhealth · Class I
- Best Choice — VALU MERCHANDISERS COMPANY · Class I
- MediBrief — MEDI-TECH INTERNATIONAL CORPORATION · Class I
- Abena — ABENA NORTH AMERICA, INC. · Class I
- Abena — ABENA NORTH AMERICA, INC. · Class I
- Abena — ABENA NORTH AMERICA, INC. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fourstar Group Inc.
Sources (1)
- FDA UDI f3d4ea9d-83a2-4877-91a6-cfcf6ad43ef0 33 fields · synced May 30, 2026