Identity
- Trade Name
- ManaMed Inc FDA UDI
- Generic Name
- Moist-cold pack FDA UDI
- Device Name
- ManaEZ Ice Wrist is a quick fitting, universal, wrist orthosis. This wrist 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 wrist FDA UDI
- Model / Reference
- ManaEZ Ice Wrist FDA UDI
- Description
- ManaEZ Ice Wrist is a quick fitting, universal, wrist orthosis. This wrist 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 wrist FDA UDI
Identifiers
- Catalog Number
- EZIWST01 FDA UDI
- Primary DI / UDI-DI
- 00810113682600 FDA UDI
- FDA Product Code
- KYR FDA UDIILH FDA UDI
- GMDN Term
- Moist-cold pack FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6050 FDA UDI890.3475 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
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Wrist immobilizer, reusableMoist-cold pack
ManaMed Inc by Manamed Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 8854657b-cd8c-4529-b0e1-655e4cfe2bd3 35 fields · synced May 31, 2026