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Epix Electrosurgical Probe with Smoke Evacuation - L-Hook
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Epix Electrosurgical Probe with Smoke Evacuation - L-Hook FDA UDI
- Generic Name
- Endoscopic electrosurgical handpiece/electrode, monopolar, single-use FDA UDI
- Device Name
- 5mm x 42cm - Angled Shaft - L-hook Tip FDA UDI
- Model / Reference
- CW002 FDA UDI
- Description
- 5mm x 42cm - Angled Shaft - L-hook Tip FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00607915136147 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Endoscopic 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 5 Millimeter FDA UDIShaft Length — 42 Centimeter FDA UDI
Category: Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
Epix Electrosurgical Probe with Smoke Evacuation - L-Hook by Applied Medical Resources Corp. — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Endoscopic electrosurgical handpiece/electrode, monopolar, single-use.
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- Arthrex® — Arthrex, Inc. · Class II
- Short Throw — US Endoscopy · Class II
- Single Use Electrosurgical Knife KD-655 — Olympus Medical Systems Corporation · Class II
- Polyp Pak — US Endoscopy · Class II
- ZKSK — Beijing ZKSK Technology 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
- Applied Medical Resources Corp.
Sources (1)
- FDA UDI 12260736-63f5-4c1d-bedf-1d4ef0c9d0bc 35 fields · synced Jun 6, 2026