Identity
- Trade Name
- Puritan Histobrush® FDA UDI
- Generic Name
- Cytology scraper, single-use FDA UDI
- Device Name
- Cervical Cytology Devices, Sterile EUDAMEDHistobrush 8” Sterile Soft Tapered Nylon Bristles Cytology Brush w/Polystyrene Handle - 25-2188 FDA UDI
- Model / Reference
- 25-2188 EUDAMEDFDA UDI
- Description
- Histobrush 8” Sterile Soft Tapered Nylon Bristles Cytology Brush w/Polystyrene Handle - 25-2188 FDA UDI
Identifiers
- Catalog Number
- 25-2188 FDA UDI
- Primary DI / UDI-DI
- 00609576325045 EUDAMEDFDA UDI
- Basic UDI-DI
- 0609576CCDSY8 EUDAMED
- 510(k) Number
- K111681 FDA UDI
- FDA Product Code
- HHT FDA UDI
- EMDN Code
- U089002 DEVICES FOR GYNAECOLOGICAL CYTOLOGY EUDAMED
- GMDN Term
- Cytology scraper, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 884.4530 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Puritan Histobrush® by Puritan Medical Products Company Llc — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Cytology scraper, single-use.
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Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| 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 (2)
- FDA UDI a7f645c9-8547-4504-be12-715e97ee4d25 35 fields · synced Jun 19, 2026
- EUDAMED 7ddb7b18-fbf8-4445-879a-49e8aa1c7bc1 61 fields · synced Jun 19, 2026