E-Line

FDA UDI

Class II (US FDA UDI)

by Richard Wolf GmbH

Identity

Trade Name: E-LINE FDA UDI
Generic Name: Rigid endoscopic biopsy forceps, reusable FDA UDI
Device Name: OPT.BIOPSY FORCEPS SPOON-SHAPED double-action, through cutting, for biopsies, for sheaths from 14Fr, for telescope 0° Ø, for telescope 0° Ø 2.7mm, with twist lock, reusable FDA UDI
Model / Reference: 8672604 FDA UDI
Description: OPT.BIOPSY FORCEPS SPOON-SHAPED double-action, through cutting, for biopsies, for sheaths from 14Fr, for telescope 0° Ø, for telescope 0° Ø 2.7mm, with twist lock, reusable FDA UDI

Identifiers

Catalog Number: 8672.604 FDA UDI
Primary DI / UDI-DI: 04055207019504 FDA UDI
FDA Product Code: GEI FDA UDI
GMDN Term: Rigid endoscopic biopsy forceps, reusable 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

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

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

Category: Rigid endoscopic biopsy forceps, reusable

E-Line by Richard Wolf GmbH — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Richard Wolf GmbH

Sources (1)

FDA UDI ec12c792-c113-4a2b-8e87-ddbfeeef2204 35 fields · synced Jun 6, 2026