Identity
- Trade Name
- E-LINE FDA UDI
- Generic Name
- Stone/foreign-body extraction set FDA UDI
- Device Name
- WORKING ELEMENT FOR PUNCH-LITHO 24-28FR closed, SL 242mm, round, distal end straight, compatible with sheaths from 24-28Fr, continuous irrigation sheaths from 26Fr, and telescopes Ø 4mm, 0°-30°, reusable FDA UDI
- Model / Reference
- 865490 FDA UDI
- Description
- WORKING ELEMENT FOR PUNCH-LITHO 24-28FR closed, SL 242mm, round, distal end straight, compatible with sheaths from 24-28Fr, continuous irrigation sheaths from 26Fr, and telescopes Ø 4mm, 0°-30°, reusable FDA UDI
Identifiers
- Catalog Number
- 8654.90 FDA UDI
- Primary DI / UDI-DI
- 04055207010976 FDA UDI
- FDA Product Code
- FBO FDA UDI
- GMDN Term
- Stone/foreign-body extraction set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- Not 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
E-Line by Richard Wolf GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 0f8cb4b6-ed1b-4057-a3c0-b5d614e0ff4d 36 fields · synced May 30, 2026