Identity
- Trade Name
- Lateral Positioner, Refurbished FDA UDI
- Generic Name
- Operating table torso positioner FDA UDI
- Model / Reference
- 5300R FDA UDI
Identifiers
- Catalog Number
- 5300R FDA UDI
- Primary DI / UDI-DI
- 00842430102387 FDA UDI
- FDA Product Code
- JEA FDA UDI
- GMDN Term
- Operating table torso positioner 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
Yes
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: Operating table torso positioner
Lateral Positioner, Refurbished by Mizuho Orthopedic Systems, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Operating table torso positioner.
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- Schaerer Medical USA — Schaerer Medical Usa, Inc. · Class I
- Schaerer Medical USA — Schaerer Medical Usa, Inc. · Class I
- Universal Lateral Positioner® — INNOVATIVE MEDICAL PRODUCTS, INC. · Class I
- SINGLE LOOP PREPPER — AliMed, LLC · 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
- Mizuho Orthopedic Systems, Inc.
Sources (1)
- FDA UDI 09678553-ef67-476d-9097-d0c9aec77f79 34 fields · synced Jun 9, 2026