Identity
- Trade Name
- Puritan Histobrush Cytology Brush FDA UDI
- Generic Name
- Cytology scraper, single-use FDA UDI
- Device Name
- Cervical Cytology Devices, Non-Sterile EUDAMEDNon-sterile Histobrush Cytology Brush. 7" length, plastic handle, soft nylon bristle head. FDA UDI
- Model / Reference
- 2199 EUDAMEDHistobrush FDA UDI
- Description
- Non-sterile Histobrush Cytology Brush. 7" length, plastic handle, soft nylon bristle head. FDA UDI
Identifiers
- Catalog Number
- 2199 FDA UDI
- Primary DI / UDI-DI
- 00609576250071 EUDAMED30609576250072 FDA UDI
- Basic UDI-DI
- 0609576CCDNSRP EUDAMED
- Unit of Use DI
- 30609576250072 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
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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 Cytology Brush by Puritan Medical Products Company Llc — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Cytology scraper, single-use.
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- 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
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 69fa1248-d4e9-4b65-b40a-50285ee1ffce 35 fields · synced Jul 18, 2026
- EUDAMED 462b92f8-e529-4c91-a6fc-1a490d088d27 61 fields · synced Jul 18, 2026