Identity
- Trade Name
- Mindray FDA UDI
- Generic Name
- Operating table orthopaedic extension, non-powered FDA UDI
- Model / Reference
- Orthopaedic Extension Device kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06948350529786 FDA UDI
- FDA Product Code
- JEA FDA UDI
- GMDN Term
- Operating table orthopaedic extension, non-powered 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Operating table orthopaedic extension, non-powered
Mindray by Nanjing Mindray Bio-Medical Electronics Co., Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Operating table orthopaedic extension, non-powered.
- General Instruments — ALPHATEC SPINE, INC. · Class I
- Foot plate — Maquet, Inc. · Class I
- 55" Imaging Extension, Kit — Composite Manufacturing, Inc. · Class I
- LIF-PTP — ALPHATEC SPINE, INC. · Class I
- Pivot Guardian — Stryker Corp. · Class I
- FLEXION TROLLEY 519550 — Merivaara Oy · Class I
- Adapter clamp for femur countertraction — Maquet, Inc. · Class I
- Illico — ALPHATEC SPINE, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nanjing Mindray Bio-Medical Electronics Co., Ltd
Sources (1)
- FDA UDI 772a04d0-7a33-4764-b453-fe6748e24ff0 32 fields · synced Jun 1, 2026