Identity
- Trade Name
- Rovers EndoCervex Brush FDA UDI
- Generic Name
- Cytology scraper, single-use FDA UDI
- Device Name
- Rovers 8” Soft Flexible Cervex Brush w/Polyethylene Handle - 2195 FDA UDI
- Model / Reference
- 2195 FDA UDI
- Description
- Rovers 8” Soft Flexible Cervex Brush w/Polyethylene Handle - 2195 FDA UDI
Identifiers
- Catalog Number
- 2195 FDA UDI
- Primary DI / UDI-DI
- 10609576250092 FDA UDI
- FDA Product Code
- HHT FDA UDI
- GMDN Term
- Cytology scraper, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.4530 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
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 EndoCervex Brush by Puritan Medical Products Company Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cytology scraper, single-use.
- Rovers® Orcellex® Brush RT — Rovers Medical Devices B.V. · Class I
- Barrx — Covidien LP · Class I
- Rovers® Cervex-Brush® — Rovers Medical Devices B.V. · Class II
- Rovers® EndoCervex-Brush® — Rovers Medical Devices B.V. · Class II
- Papette — CooperSurgical, Inc. · Class II
- Rovers® Cervex-Brush® Combi — Rovers Medical Devices B.V. · Class II
- Grafco — GF Health Products, Inc · Class II
- Rovers® EndoCervex-Brush®-S — Rovers Medical Devices B.V. · 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
- Puritan Medical Products Company Llc
Sources (1)
- FDA UDI aca1e357-2b4f-4a67-bde5-93ee1d70a1ec 34 fields · synced May 30, 2026