Identity
- Trade Name
- ManaMed FDA UDI
- Generic Name
- Shoulder immobilizer/orthosis, single-use FDA UDI
- Device Name
- The Mini Kahuna Brace is universal and can be applied to right or left side. The breathable material allows for comfort and optimal patient experience. The Mini Kahuna brace fits the description of the L3670 HCPC. Mini Kahuna comes with abduction pillow and ball. Universal Used for arthroscopic, anterior, or rotator cuff repairs FDA UDI
- Model / Reference
- Mini Kahuna Brace FDA UDI
- Description
- The Mini Kahuna Brace is universal and can be applied to right or left side. The breathable material allows for comfort and optimal patient experience. The Mini Kahuna brace fits the description of the L3670 HCPC. Mini Kahuna comes with abduction pillow and ball. Universal Used for arthroscopic, anterior, or rotator cuff repairs FDA UDI
Identifiers
- Catalog Number
- MKB001 FDA UDI
- Primary DI / UDI-DI
- 00810113681597 FDA UDI
- FDA Product Code
- IQQ FDA UDI
- GMDN Term
- Shoulder immobilizer/orthosis, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3420 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
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
Category: Shoulder immobilizer/orthosis, single-use
ManaMed 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 95b09a38-7ed7-486a-9264-d287ff7cd912 34 fields · synced Jun 8, 2026