Identity
- Trade Name
- ERAGON MODULAR FDA UDI
- Generic Name
- Rigid endoscopic biopsy forceps, reusable FDA UDI
- Device Name
- SHEATH TUBE Ø 10MM SL 387MM Compatible with all ERAGONmodular 10mm inserts in the respective sheath length, along with ERAGONmodular and ERAGONaxial handles without an HF connection, reusable FDA UDI
- Model / Reference
- 8397902 FDA UDI
- Description
- SHEATH TUBE Ø 10MM SL 387MM Compatible with all ERAGONmodular 10mm inserts in the respective sheath length, along with ERAGONmodular and ERAGONaxial handles without an HF connection, reusable FDA UDI
Identifiers
- Catalog Number
- 8397902 FDA UDI
- Primary DI / UDI-DI
- 04055207056288 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Rigid endoscopic biopsy forceps, 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
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 387 Millimeter FDA UDIOuter Diameter — 10 Millimeter FDA UDI
Category: Rigid endoscopic biopsy forceps, reusable
Eragon Modular by Richard Wolf GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- ELMED — ELMED INCORPORATED · 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
- Richard Wolf GmbH
Sources (1)
- FDA UDI ce2d8901-2d36-4f02-90bf-4f0b038b92ae 36 fields · synced May 30, 2026