Identity
- Trade Name
- Remora Smoke and Fluid Evacuation System FDA UDI
- Generic Name
- Surgical plume evacuation system FDA UDI
- Device Name
- Remora Smoke and Fluid Evacuation System (Sterile, Pouched), MDR FDA UDI
- Model / Reference
- EST9000 FDA UDI
- Description
- Remora Smoke and Fluid Evacuation System (Sterile, Pouched), MDR FDA UDI
Identifiers
- Catalog Number
- EST9000, ST9000 FDA UDI
- Primary DI / UDI-DI
- 00842071139346 FDA UDI
- 510(k) Number
- K971758 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Surgical plume evacuation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Surgical plume evacuation system
Remora Smoke and Fluid Evacuation System by Applied Medical Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K971758 also covers:
- Abeon Remora MICRO Smoke and Fluid Evacuation System — Applied Medical Technology, Inc.
- Abeon Remora Smoke and Fluid Evacuation System — Applied Medical Technology, Inc.
- Abeon Remora XL Smoke and Fluid Evacuation System — Applied Medical Technology, Inc.
- Remora Smoke and Fluid Evacuation System — Applied Medical Technology, Inc.
- Surgiform SAF-T-VAC Smoke and Fluid Tube Evacuator — Applied Medical Technology, Inc.
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 II | Pending data |
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Manufacturer
- Manufacturer
- Applied Medical Technology, Inc.
Sources (1)
- FDA UDI d8232ceb-dc64-421b-8e91-81c999854a9f 36 fields · synced Jun 9, 2026