Identity
- Trade Name
- Amsco FDA UDI
- Generic Name
- Universal operating table, electromechanical FDA UDI
- Device Name
- The AMSCO 3085 SP Surgical Table, I/A Compatible Tabletop with 2-inch TLT Pads and X-Ray Top is a mobile, electrohydraulically operated general surgical table providing flexible articulation of the surgical patient. FDA UDI
- Model / Reference
- 3085 SP Surgical Table FDA UDI
- Description
- The AMSCO 3085 SP Surgical Table, I/A Compatible Tabletop with 2-inch TLT Pads and X-Ray Top is a mobile, electrohydraulically operated general surgical table providing flexible articulation of the surgical patient. FDA UDI
Identifiers
- Catalog Number
- ST010502 FDA UDI
- Primary DI / UDI-DI
- 00724995155094 FDA UDI
- 510(k) Number
- K971307 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Universal operating table, electromechanical
Amsco by Steris Corporation — 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
- 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
- Clarity — Skytron, LLC · Class I
- Auxiliary base connector kit — Skytron, LLC · Class I
- TS 7500 — Baxter Medical Systems GmbH + Co. KG · Class I
Cleared under the same submission
K971307 also covers:
- Amsco — STERIS CORPORATION
- Amsco — STERIS CORPORATION
- Amsco — STERIS CORPORATION
- Amsco — STERIS CORPORATION
- Amsco — STERIS CORPORATION
- Amsco — STERIS CORPORATION
- Amsco — STERIS CORPORATION
- Amsco — STERIS CORPORATION
- Amsco — STERIS CORPORATION
- Amsco — STERIS CORPORATION
- Amsco — STERIS CORPORATION
- Amsco — STERIS CORPORATION
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
- Steris Corporation
Sources (1)
- FDA UDI 139ac80d-529b-4bf3-ab24-fec2928614ec 36 fields · synced Jun 8, 2026