Identity
- Trade Name
- WELLBRACE FDA UDI
- Generic Name
- Foot orthosis FDA UDI
- Device Name
- ORTHOPEDIC METATARSAL BAND - SIZE S FDA UDI
- Model / Reference
- 1301-401 U S FDA UDI
- Description
- ORTHOPEDIC METATARSAL BAND - SIZE S FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07798094548791 FDA UDI
- FDA Product Code
- IQI FDA UDI
- GMDN Term
- Foot orthosis FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3475 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: Foot orthosis
Wellbrace by Pantymed S.a. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Foot orthosis.
- POST-OP SHOE W/O BUCKLES WOM LG — BIRD & CRONIN, LLC · Class I
- Ambroise — Ambroise Holland B.V. · Class I
- DONJOY — DJO, LLC · Class I
- HAPAD METATARSAL COOKIES MENS — BIRD & CRONIN, LLC · Class I
- Phantom Dorsal Night Splint — MEDICAL SPECIALTIES INCORPORATED · Class I
- DONJOY PERFORMANCE — DJO, LLC · Class I
- POST-OP SHOE DLX 1 PED BOXED — BIRD & CRONIN, LLC · Class I
- POST-OP SHOE DLX.2 MALE XL — BIRD & CRONIN, 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 dd6d4e20-c233-4af6-a071-4a57dae528c5 33 fields · synced Jun 1, 2026