Identity
- Trade Name
- ManaMed Inc FDA UDI
- Generic Name
- Shoulder support/thermal therapy bandage FDA UDI
- Device Name
- ManaEZ Ice Wrap Shoulder is a quick fitting, universal, shoulder orthosis. This shoulder brace also includes an ice pack. Removable ice pack Lightweight, latex free breathable material Effortless application, universal size with hook and loop closure Designed for either left or right shoulder FDA UDI
- Model / Reference
- ManaEZ Ice Wrap Shoulder FDA UDI
- Description
- ManaEZ Ice Wrap Shoulder is a quick fitting, universal, shoulder orthosis. This shoulder brace also includes an ice pack. Removable ice pack Lightweight, latex free breathable material Effortless application, universal size with hook and loop closure Designed for either left or right shoulder FDA UDI
Identifiers
- Catalog Number
- EZIWSHLDR01 FDA UDI
- Primary DI / UDI-DI
- 00810113682532 FDA UDI
- FDA Product Code
- KYR FDA UDIIQQ FDA UDI
- GMDN Term
- Shoulder support/thermal therapy bandage FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6050 FDA UDI890.3420 FDA UDI
- Commercial Distribution
- Not 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
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
ManaMed Inc by Manamed Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
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Manufacturer
- Manufacturer
- Manamed Llc
Sources (1)
- FDA UDI 70e1e497-cbb1-44d7-afa8-cf7af80fa9d3 36 fields · synced May 30, 2026