Identity
- Trade Name
- ManaMed FDA UDI
- Generic Name
- Shoulder immobilizer/orthosis, reusable FDA UDI
- Device Name
- The Kangaroo Sling is universal and can be applied to right or left side. The breathable material allows for comfort and optimal patient experience. Kangaroo Sling comes with patent pending abduction pillow. Universal sizing, can be applied to left or right side of the patient. Abduction pillow allows user to carry water, coffee, and a mobile phone. FDA UDI
- Model / Reference
- Kangaroo Shoulder Sling FDA UDI
- Description
- The Kangaroo Sling is universal and can be applied to right or left side. The breathable material allows for comfort and optimal patient experience. Kangaroo Sling comes with patent pending abduction pillow. Universal sizing, can be applied to left or right side of the patient. Abduction pillow allows user to carry water, coffee, and a mobile phone. FDA UDI
Identifiers
- Catalog Number
- KSS001 FDA UDI
- Primary DI / UDI-DI
- 00810113680880 FDA UDI
- FDA Product Code
- ILI FDA UDI
- GMDN Term
- Shoulder immobilizer/orthosis, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3640 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Shoulder immobilizer/orthosis, reusable
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 62216d6d-7c16-4c2f-b2ce-d0dc866bd921 35 fields · synced May 30, 2026