Identity
- Trade Name
- ERAGON MODULAR FDA UDI
- Generic Name
- Endoscopic electrosurgical handpiece/electrode, monopolar, reusable FDA UDI
- Device Name
- GRASP. FORCEPS INSERT Ø 5MM atraumatic, narrow and rounded, jaw length 15mm, for SL 450mm, double action, reusable FDA UDI
- Model / Reference
- 8394230 FDA UDI
- Description
- GRASP. FORCEPS INSERT Ø 5MM atraumatic, narrow and rounded, jaw length 15mm, for SL 450mm, double action, reusable FDA UDI
Identifiers
- Catalog Number
- 8394230 FDA UDI
- Primary DI / UDI-DI
- 04055207055960 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Endoscopic electrosurgical handpiece/electrode, monopolar, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Outer Diameter — 5 Millimeter FDA UDI
Category: Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
The ERAGON MODULAR is an endoscopic electrosurgical handpiece/electrode, monopolar, reusable device designed for atraumatic cutting/coagulation/ablation during endoscopic surgery. Available in various forms, including forceps or snare with ring handles, and a long thin electrode connected to the handpiece.
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Authorization Coverage (1 country)
Regulatory Authorizations
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
- Richard Wolf GmbH
Sources (1)
- FDA UDI 203f79dc-dded-4357-ba09-338a4cd30956 36 fields · synced Jun 27, 2026