Identity
- Trade Name
- StatLab FDA UDI
- Generic Name
- General-purpose cytology brush FDA UDI
- Device Name
- Cervical brush, sterile, scored FDA UDI
- Model / Reference
- CB500-100 FDA UDI
- Description
- Cervical brush, sterile, scored FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971317521776 FDA UDI
- FDA Product Code
- GEE FDA UDI
- GMDN Term
- General-purpose cytology brush FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
No
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
Yes
FDA UDI
Category: General-purpose cytology brush
StatLab by Yancheng Huida Medical Instruments Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose cytology brush.
- Hobbs Nasal Cytology Brush — HOBBS MEDICAL, INC. · Class I
- Hobbs Nasal Cytology Brush — HOBBS MEDICAL, INC. · Class I
- Fistula Brush — Ovesco Endoscopy AG · Class I
- StatLab — Yancheng Huida Medical Instruments Co., Ltd. · Class I
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
- Yancheng Huida Medical Instruments Co., Ltd.
Sources (1)
- FDA UDI 0f866769-bdbc-40ee-ace4-036b3c8ba91f 33 fields · synced May 30, 2026