Identity
- Trade Name
- Shoulder Brace with Airplane Kit FDA UDI
- Generic Name
- Shoulder immobilizer/orthosis, reusable FDA UDI
- Device Name
- The Shoulder Brace with Airplane Kit provides support for shoulder surgeries in a universal multiple configuration brace. Suitable for all shoulder surgeries as well as conservative care of shoulder injuries. The Shoulder Brace with Airplane Kit is your new go to shoulder brace for all your clinical needs. Sized universal Low-profile design True Airplane or Gunslinger alignment Two step application Multiple abduction angles Extreme external rotation FDA UDI
- Model / Reference
- OSAK3 FDA UDI
- Description
- The Shoulder Brace with Airplane Kit provides support for shoulder surgeries in a universal multiple configuration brace. Suitable for all shoulder surgeries as well as conservative care of shoulder injuries. The Shoulder Brace with Airplane Kit is your new go to shoulder brace for all your clinical needs. Sized universal Low-profile design True Airplane or Gunslinger alignment Two step application Multiple abduction angles Extreme external rotation FDA UDI
Identifiers
- Catalog Number
- OSAK3 FDA UDI
- Primary DI / UDI-DI
- 00810113683027 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
Shoulder Brace with Airplane Kit by Manamed Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Shoulder immobilizer/orthosis, reusable.
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- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · 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 |
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Manufacturer
- Manufacturer
- Manamed Llc
Sources (1)
- FDA UDI ebff9f82-3a8b-4fd9-9874-e49d974f1c65 35 fields · synced Jun 1, 2026