Identity
- Trade Name
- Valleylab FDA UDI
- Generic Name
- Open-surgery electrosurgical handpiece/electrode, monopolar, single-use FDA UDI
- Device Name
- Valleylab Suction Coagulator 10FR/CH (3.33mm), 6" (15.24 cm) Non-Sterile Bulk FDA UDI
- Model / Reference
- E250510FRNSB FDA UDI
- Description
- Valleylab Suction Coagulator 10FR/CH (3.33mm), 6" (15.24 cm) Non-Sterile Bulk FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521038967 FDA UDI
- FDA Product Code
- GEI 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
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 6 Inch FDA UDICatheter Gauge — 10 French FDA UDI
Category: Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
Valleylab by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Open-surgery electrosurgical handpiece/electrode, monopolar, single-use.
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- Disposable Bipolar Suction Coagulator 7 1/2in. (19cm) 8 Fr — KIRWAN SURGICAL PRODUCTS LLC · Class IIb
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- PlasmaBladeTM — MEDTRONIC NAVIGATION, INC. · Class II
- Victan — Jiangsu Haize Medical Scientific Development Co., Ltd. · 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 |
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Manufacturer
- Manufacturer
- Covidien LP
Sources (1)
- FDA UDI 2a75471a-0ed3-444e-80bb-20a9dc73832d 36 fields · synced May 31, 2026