Identity
- Trade Name
- FNA WESTCOTT FDA UDI
- Generic Name
- Body aspiration needle, single-use FDA UDI
- Device Name
- Aspiration Needle for biopsies on soft tissue 20G x 100mm FDA UDI
- Model / Reference
- WE20100-01 FDA UDI
- Description
- Aspiration Needle for biopsies on soft tissue 20G x 100mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08053329376907 FDA UDI
- 510(k) Number
- K181803 FDA UDI
- FDA Product Code
- KNW FDA UDI
- GMDN Term
- Body aspiration needle, 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
MR Unsafe FDA UDI
Category: Body aspiration needle, single-use
Fna Westcott by Medax Unipersonale Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Body aspiration needle, single-use.
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- COMPLETE-CHIBA MR — STERYLAB SRL · Class II
- Invivo — Philips DS North America LLC · Class II
- BIOMOL — H.S. HOSPITAL SERVICE SPA · Class II
- MReye — COOK INCORPORATED · Class II
Cleared under the same submission
K181803 also covers:
- CHIBA — Medax Unipersonale Srl
- CHIBA — Medax Unipersonale Srl
- CHIBA — Medax Unipersonale Srl
- CHIBA — Medax Unipersonale Srl
- CHIBA — Medax Unipersonale Srl
- CHIBA — Medax Unipersonale Srl
- CHIBA — Medax Unipersonale Srl
- CHIBA — Medax Unipersonale Srl
- FNA CHIBA — Medax Unipersonale Srl
- FNA CHIBA — Medax Unipersonale Srl
- FNA CHIBA — Medax Unipersonale Srl
- FNA FRANSEEN — Medax Unipersonale Srl
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
- Medax Unipersonale Srl
Sources (1)
- FDA UDI f3ba6cba-bc08-44fc-a3c9-73d63ffc6040 34 fields · synced Jun 1, 2026