Identity
- Trade Name
- EvaQMax Laparo FDA UDI
- Generic Name
- Surgical plume evacuation system tube FDA UDI
- Device Name
- Tube type Laparoscopic Smoke Evacuation Device, 16 Ft(5M) hose FDA UDI
- Model / Reference
- TS5 FDA UDI
- Description
- Tube type Laparoscopic Smoke Evacuation Device, 16 Ft(5M) hose FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809083944919 FDA UDI
- FDA Product Code
- GAZ FDA UDI
- GMDN Term
- Surgical plume evacuation system tube FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6740 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
Yes
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 tube
EvaQMax Laparo by Bioprotech Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical plume evacuation system tube.
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- Gynex — GYNEX CORPORATION · Class I
- Buffalo Filter — Conmed Corporation · Class II
- Smoke Tubing — I.C. Medical, Inc. · Class II
- STERILE SURGICAL SCISSORS — Anhui Medfaith Medical Devices Co., Ltd. · 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 II | Pending data |
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Manufacturer
- Manufacturer
- Bioprotech Inc.
Sources (1)
- FDA UDI 6f52960d-01e5-43e1-9b6e-445e6834d20d 34 fields · synced May 30, 2026