Identity
- Trade Name
- Rovers® Evalyn® Brush FDA UDI
- Generic Name
- Cytology scraper, single-use FDA UDI
- Device Name
- Vaginal cell sampler, sterile FDA UDI
- Model / Reference
- 380500131 FDA UDI
- Description
- Vaginal cell sampler, sterile FDA UDI
Identifiers
- Primary DI / UDI-DI
- 18719189246435 FDA UDI
- FDA Product Code
- KXG FDA UDI
- GMDN Term
- Cytology scraper, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6025 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cytology scraper, single-use
Rovers® Evalyn® Brush by Rovers Medical Devices B.V. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Cytology scraper, single-use.
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- LabChoice Cell Scraper, Sterile, 25 cm — Dynarex Corp. · Class I
- Puritan Histobrush — PURITAN MEDICAL PRODUCTS COMPANY LLC · 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 I | Pending data |
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Manufacturer
- Manufacturer
- Rovers Medical Devices B.V.
Sources (1)
- FDA UDI 2d3f2aac-6ef4-4cd2-8b9a-9b791b82f55a 34 fields · synced May 30, 2026