Identity
- Trade Name
- OES HYSTEROFIBERSCOPE FDA UDI
- Generic Name
- Flexible fibreoptic hysteroscope FDA UDI
- Device Name
- OES HYSTEROFIBERSCOPE FDA UDI
- Model / Reference
- OLYMPUS HYF TYPE XP FDA UDI
- Description
- OES HYSTEROFIBERSCOPE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04953170411571 FDA UDI
- FDA Product Code
- HIH FDA UDI
- GMDN Term
- Flexible fibreoptic hysteroscope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1690 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Flexible fibreoptic hysteroscope
Oes Hysterofiberscope by Olympus Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flexible fibreoptic hysteroscope.
- Endosee System — CooperSurgical, Inc. · Class II
- Endosee — CooperSurgical, Inc. · Class II
- LUMINELLE DTx Hysteroscopy System — Uvision360, Inc. · Class II
- Endosee — CooperSurgical, Inc. · Class II
- Endosee System Convenience Kit — CooperSurgical, Inc.
- Luminelle DTx Control Hub — Uvision360, Inc. · Class II
- Uvision Hysteroscope Cable — Uvision360, Inc. · Class II
- Endosee — CooperSurgical, Inc. · 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 Medical Systems Corporation
Sources (1)
- FDA UDI 64b1df34-bcd0-418c-85c2-3034f7a736ec 34 fields · synced May 30, 2026