Identity
- Trade Name
- SpiraBrush CX FDA UDI
- Generic Name
- Cervical cytology scraper, single-use FDA UDI
- Device Name
- SpiraBrush CX is intended for obtaining a biopsy of visible exocervical lesions for the purpose of obtaining tissue diagnosis in women with intraepithelial disease. FDA UDI
- Model / Reference
- SBX-9000 FDA UDI
- Description
- SpiraBrush CX is intended for obtaining a biopsy of visible exocervical lesions for the purpose of obtaining tissue diagnosis in women with intraepithelial disease. FDA UDI
Identifiers
- Catalog Number
- SBX-9000 FDA UDI
- Primary DI / UDI-DI
- 00860275000309 FDA UDI
- 510(k) Number
- K011488 FDA UDI
- FDA Product Code
- HFB FDA UDI
- GMDN Term
- Cervical cytology scraper, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 884.4530 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
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: Cervical cytology scraper, single-use
SpiraBrush CX by Histologics Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Spatula — CooperSurgical, Inc. · 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
- Histologics Llc
Sources (1)
- FDA UDI 1c44b40c-03f0-4a88-910e-55438bdb76fd 36 fields · synced May 30, 2026