Identity
- Trade Name
- E-LINE FDA UDI
- Generic Name
- Rigid endoscope obturator FDA UDI
- Device Name
- VIEWING OBTURATOR RESECTOSCOPE 24FR color code yellow, WL 232mm, rounded distal end, compatible with E-Line sheaths 8654074, 8661074, 8663074, 8655384, 8654374, 8661374, 8663.374, and telescopes Ø 4mm, 0°/12°/30°, bayonet-cap, reusable FDA UDI
- Model / Reference
- 841512 FDA UDI
- Description
- VIEWING OBTURATOR RESECTOSCOPE 24FR color code yellow, WL 232mm, rounded distal end, compatible with E-Line sheaths 8654074, 8661074, 8663074, 8655384, 8654374, 8661374, 8663.374, and telescopes Ø 4mm, 0°/12°/30°, bayonet-cap, reusable FDA UDI
Identifiers
- Catalog Number
- 8415.12 FDA UDI
- Primary DI / UDI-DI
- 04055207010044 FDA UDI
- FDA Product Code
- FJL FDA UDI
- GMDN Term
- Rigid endoscope obturator 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
- Outer Diameter — 8 Millimeter FDA UDI
Category: Rigid endoscope obturator
E-Line by Richard Wolf GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rigid endoscope obturator.
- Arthroscopy bridge — SOPRO-COMEG GmbH · Class II
- Biportal Laminoscope, ocular — Joimax GmbH · Class IIa
- TAUT — TELEFLEX INCORPORATED · Class II
- Hysteroscopy obturator — SOPRO-COMEG GmbH · Class II
- USA Elite — Gyrus Acmi, Inc. · Class II
- Trabecular Metal® — Zimmer, Inc. · Class I
- Obturator — SOPRO-COMEG GmbH · Class II
- Obturator — SOPRO-COMEG GmbH · 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 e483258e-bae7-472d-a3c6-0880910fec70 36 fields · synced May 30, 2026