Identity
- Trade Name
- AURORA Evacuator FDA UDI
- Generic Name
- General-purpose surgical suction system, vacuum FDA UDI
- Device Name
- The AURORA Evacuator is provided sterile, for single-use only. It is a disposable, handheld, aspiration device designed to remove fluids and soft tissue during minimally invasive surgical procedures. FDA UDI
- Model / Reference
- AURORA Evacuator-13 FDA UDI
- Description
- The AURORA Evacuator is provided sterile, for single-use only. It is a disposable, handheld, aspiration device designed to remove fluids and soft tissue during minimally invasive surgical procedures. FDA UDI
Identifiers
- Catalog Number
- AURORA Evacuator-13 FDA UDI
- Primary DI / UDI-DI
- 00860624000417 FDA UDI
- 510(k) Number
- K180372 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- General-purpose surgical suction system, vacuum 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
No
FDA UDI
Category: General-purpose surgical suction system, vacuum
A general-purpose surgical suction system, vacuum for minimally invasive surgical procedures. The AURORA Evacuator is a disposable, handheld device provided sterile for single-use only.
Similar devices
Also classified as General-purpose surgical suction system, vacuum.
- Drager — Allied Medical LLC · Class II
- Phantom — Innovative Med, Inc. · Class II
- GOMCO — Allied Medical LLC · Class II
- Orthopaedic Suction Set — GCMEDICA ENTERPRISE LTD.(WUXI) · Class II
- Schuco — Allied Medical LLC · Class II
- ADULT TIP SUCKER HEX HANDLE WITH VENT — NOVOSCI CORP. · Class II
- XinjingProWellness™ — Tianjin Newtrans Technology Development · Class II
- TIP SUCKER — NOVOSCI CORP. · Class II
Cleared under the same submission
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
- Rebound Therapeutics, Corporation
Sources (1)
- FDA UDI a969eeef-c17e-417b-9c63-aa7d4a69c24c 35 fields · synced Jul 14, 2026