Identity
- Trade Name
- Valleylab FDA UDI
- Generic Name
- Surgical plume evacuation system tube FDA UDI
- Device Name
- Smoke Attachment FDA UDI
- Model / Reference
- E3810 FDA UDI
- Description
- Smoke Attachment FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521751309 FDA UDI
- 510(k) Number
- K152031 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Surgical plume evacuation system tube 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
Dimensions & Sizes
- Size
- Length — 10 Feet FDA UDI
Category: Surgical plume evacuation system tube
Valleylab by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical plume evacuation system tube.
- BCL Accessories Kit — CairnSurgical Inc · Class IIb
- Surgimedics® — COASTAL LIFE TECHNOLOGIES, INC. · Class I
- SUSI® — Aesculap AG · Class IIa
- 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
- Bovie — BOVIE MEDICAL CORPORATION · Class II
Cleared under the same submission
K152031 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Covidien LP
Sources (1)
- FDA UDI 3d3d2c0b-a077-4510-8ffb-6d2a01fd1699 37 fields · synced May 29, 2026