Identity
- Trade Name
- EasyCut FDA UDI
- Generic Name
- Body aspiration needle, single-use FDA UDI
- Device Name
- DISPOSABLE SEMIAUTOMATIC NEEDLE 18G X 200 mm FOR CYTO-HISTOLOGICAL BIOPSY ASPIRATION AS FOR MENGHINI MODIFIED FDA UDI
- Model / Reference
- PC01820 FDA UDI
- Description
- DISPOSABLE SEMIAUTOMATIC NEEDLE 18G X 200 mm FOR CYTO-HISTOLOGICAL BIOPSY ASPIRATION AS FOR MENGHINI MODIFIED FDA UDI
Identifiers
- Catalog Number
- PC01820 FDA UDI
- Primary DI / UDI-DI
- 08052440105571 FDA UDI
- 510(k) Number
- K160316 FDA UDI
- FDA Product Code
- FCG FDA UDIKNW 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
- Not 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
EasyCut by M.d.l. S.r.l. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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
- M.d.l. S.r.l.
Sources (1)
- FDA UDI 0b4c5db3-a5f2-47dd-b313-c310f00d97f2 36 fields · synced Jun 1, 2026