Identity
- Trade Name
- Armboard short with short post FDA UDI
- Generic Name
- Arm procedure positioner, reusable FDA UDI
- Model / Reference
- 10-380-KR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07350111830434 FDA UDI
- FDA Product Code
- LGX FDA UDI
- GMDN Term
- Arm procedure positioner, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4960 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
No
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: Arm procedure positioner, reusable
Accurate positioning devices for medical procedures, providing a stable and comfortable support for patients. Designed as an elongated, curved cushioned surface, these armboards are typically attached to side rails, examination tables, or chairs and offer adjustable height, tilt, rotation, and lock positioning capabilities.
Similar devices
Also classified as Arm procedure positioner, reusable.
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- MTI — MEDICAL TECHNOLOGY INDUSTRIES, INC. · Class I
- Coulmed — COULMED PRODUCTS GROUP LLC · Class I
- MTI — MEDICAL TECHNOLOGY INDUSTRIES, INC. · Class I
- ALLEN — HILL-ROM, INC. · Class I
- MTI — MEDICAL TECHNOLOGY 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
- Reison Medical AB
Sources (1)
- FDA UDI 7667fa6c-0d07-4363-9ace-23cb285c126f 32 fields · synced Jul 11, 2026