Identity
- Trade Name
- Olympus FDA UDI
- Generic Name
- Rigid endoscope working guide FDA UDI
- Device Name
- Working element, for resectoscope and optical urethrotome FDA UDI
- Model / Reference
- A37014A FDA UDI
- Description
- Working element, for resectoscope and optical urethrotome FDA UDI
Identifiers
- Catalog Number
- A37014A FDA UDI
- Primary DI / UDI-DI
- 04042761023191 FDA UDI
- FDA Product Code
- GCP FDA UDI
- GMDN Term
- Rigid endoscope working guide 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
Yes
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Rigid endoscope working guide
Olympus by Olympus Winter & Ibe GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rigid endoscope working guide.
- Saline-resectoscopy working unit, passive closed handle, 24/26/28.5Ch — mahe medical gmbh · Class II
- Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY · Class II
- Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY · Class II
- Urethrotome sheath only, 21Ch. — mahe medical gmbh · Class II
- Resectoscopy working unit, passive, closed handle, 24/26/28.5Ch — mahe medical gmbh · Class II
- mahe medical GmbH — mahe medical gmbh · Class II
- Elite — Gyrus Acmi, Inc. · Class II
- Cysto.-Urethro.-sheath, compl., 17Ch. for 4.0mm optic — mahe medical 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
- Olympus Winter & Ibe GmbH
Sources (1)
- FDA UDI 090292d3-01ba-40cc-a5b2-5397723ae46f 35 fields · synced Jun 6, 2026