Eragon Modular

FDA UDI

Class I (US FDA UDI)

by Richard Wolf GmbH

Identity

Trade Name: ERAGON MODULAR FDA UDI
Generic Name: Rigid endoscopic biopsy forceps, reusable FDA UDI
Device Name: SHEATH TUBE Ø 10MM SL 447MM 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: 8396902 FDA UDI
Description: SHEATH TUBE Ø 10MM SL 447MM 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: 8396902 FDA UDI
Primary DI / UDI-DI: 04055207056271 FDA UDI
FDA Product Code: FCL FDA UDI
GEN FDA UDI
GMDN Term: Rigid endoscopic biopsy forceps, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 876.1075 FDA UDI
878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 10 Millimeter FDA UDI
Length — 447 Millimeter FDA UDI

Category: Rigid endoscopic biopsy forceps, reusable

Eragon Modular by Richard Wolf GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 I	Pending data

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Manufacturer

Manufacturer: Richard Wolf GmbH

Sources (1)

FDA UDI 46ce6f4b-bf63-49c5-a9a3-b385c54a9f7c 36 fields · synced May 30, 2026