Identity
- Trade Name
- LEEP Disposable Universal Electrodes FDA UDI
- Generic Name
- Open-surgery electrosurgical handpiece/electrode, monopolar, single-use FDA UDI
- Device Name
- LEEP Disposable Universal Electrodes FDA UDI
- Model / Reference
- 6040 FDA UDI
- Description
- LEEP Disposable Universal Electrodes FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20888937014413 FDA UDI
- FDA Product Code
- HAM FDA UDI
- GMDN Term
- Open-surgery electrosurgical handpiece/electrode, monopolar, single-use 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
LEEP Disposable Universal Electrodes by CooperSurgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Open-surgery electrosurgical handpiece/electrode, monopolar, single-use.
- PlasmaBlade™ — MEDTRONIC NAVIGATION, INC. · Class II
- Victan — Jiangsu Haize Medical Scientific Development Co., Ltd. · Class II
- Symmetry Olsen — Olsen Medical · Class II
- Bovie — SYMMETRY SURGICAL INC. · Class II
- Disposable Bipolar Suction Coagulator 7 1/2in. (19cm) 8 Fr — KIRWAN SURGICAL PRODUCTS LLC · Class IIb
- Valleylab — Covidien LP · Class II
- A&E Medical / Disposable Suction Coagulator — A & E MEDICAL CORPORATION · Class II
- PlasmaBladeTM — MEDTRONIC NAVIGATION, INC. · Class II
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
- CooperSurgical, Inc.
Sources (1)
- FDA UDI 3319d719-e8a7-4440-8abb-19647a2fafbe 33 fields · synced Jun 9, 2026