Identity
- Trade Name
- ARMBOARD, PIVOTING W/2" PAD, REFURB FDA UDI
- Generic Name
- Arm procedure positioner, reusable FDA UDI
- Model / Reference
- 5356R FDA UDI
Identifiers
- Catalog Number
- 5356R FDA UDI
- Primary DI / UDI-DI
- 00842430103247 FDA UDI
- FDA Product Code
- JEA 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
Armboard, Pivoting W/2" Pad, Refurb by Mizuho Orthopedic Systems, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Arm procedure positioner, reusable.
- Coulmed — COULMED PRODUCTS GROUP LLC · Class I
- MTI — MEDICAL TECHNOLOGY INDUSTRIES, INC. · Class I
- Arthrex® — Arthrex, Inc. · Class I
- 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 (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mizuho Orthopedic Systems, Inc.
Sources (2)
- FDA UDI b6777392-c206-46a5-8eaf-d2548a815db7 34 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026