Identity
- Trade Name
- GYNECARE VERSAPOINT FDA UDI
- Generic Name
- Rigid optical hysteroscope FDA UDI
- Device Name
- Resectoscopic System, Hysteroscope 4.0mm 12°, High Magnification FDA UDI
- Model / Reference
- 01938 FDA UDI
- Description
- Resectoscopic System, Hysteroscope 4.0mm 12°, High Magnification FDA UDI
Identifiers
- Catalog Number
- 01938 FDA UDI
- Primary DI / UDI-DI
- 10705031000957 FDA UDI
- FDA Product Code
- HIH FDA UDI
- GMDN Term
- Rigid optical hysteroscope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1690 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
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
Gynecare Versapoint by Ethicon Inc. — 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
- Ethicon Inc.
Sources (1)
- FDA UDI 87be8e3b-5eef-4d73-ba1b-89ba46dac503 37 fields · synced May 30, 2026