Identity
- Trade Name
- Elite FDA UDI
- Generic Name
- Universal operating table, electromechanical FDA UDI
- Device Name
- Battery/line powered electro-hydraulic table with removable leg section and 210° table top rotation FDA UDI
- Model / Reference
- 6302 FDA UDI
- Description
- Battery/line powered electro-hydraulic table with removable leg section and 210° table top rotation FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10841736112189 FDA UDI
- FDA Product Code
- FQO FDA UDI
- GMDN Term
- Universal operating table, electromechanical 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
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Universal operating table, electromechanical
Elite by Skytron, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Universal operating table, electromechanical.
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- TS 7500 — Baxter Medical Systems GmbH + Co. KG · Class I
- CORIN mobile operating table — Maquet, Inc. · Class I
- TS 7500 — Baxter Medical Systems GmbH + Co. KG · Class II
- STERIS — STERIS CORPORATION · Class I
- Amsco — STERIS CORPORATION · 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
- Skytron, LLC
Sources (1)
- FDA UDI eba9513b-a0f6-42c6-975c-df7b14a1d423 35 fields · synced May 30, 2026