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Praxis Medical CytoCore and CytoCore Luer Adapters
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Praxis Medical CytoCore and CytoCore Luer Adapters FDA UDI
- Generic Name
- Biopsy syringe holder, single-use FDA UDI
- Device Name
- CytoCore device (DI 00860003935804) with extra luer adapters pouch (DI 00860003935835) FDA UDI
- Model / Reference
- C0025L FDA UDI
- Description
- CytoCore device (DI 00860003935804) with extra luer adapters pouch (DI 00860003935835) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860003935866 FDA UDI
- 510(k) Number
- K200278 FDA UDI
- FDA Product Code
- KNW FDA UDI
- GMDN Term
- Biopsy syringe holder, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1075 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
Yes
FDA UDI
Category: Biopsy syringe holder, single-use
Praxis Medical CytoCore and CytoCore Luer Adapters by Praxis Medical Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K200278 also covers:
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
- Praxis Medical Llc
Sources (1)
- FDA UDI f3894c8f-3c20-438a-83fd-b287f5b2ded0 34 fields · synced Jun 8, 2026