Identity
- Trade Name
- WELLBRACE FDA UDI
- Generic Name
- Abdominal binder, reusable FDA UDI
- Device Name
- ADJUSTABLE GIRDLE - 24 CM - size L FDA UDI
- Model / Reference
- 1205-2024 U L FDA UDI
- Description
- ADJUSTABLE GIRDLE - 24 CM - size L FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07798094548616 FDA UDI
- FDA Product Code
- KTD FDA UDI
- GMDN Term
- Abdominal binder, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3490 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Abdominal binder, reusable
Wellbrace by Pantymed S.a. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Abdominal binder, reusable.
- Momcozy — Shenzhen Lutejiacheng Technology Co., Ltd. · Class I
- Trulife — TRULIFE, INC. · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- AZMED — Hengshui Tianjian Medical Supplies CO., LTD · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- PROCARE — DJO, LLC · 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
- Pantymed S.a.
Sources (1)
- FDA UDI f9bf33f6-b208-404f-8c97-e58a755f0a7f 33 fields · synced May 30, 2026