Identity
- Trade Name
- EasyCut FDA UDI
- Generic Name
- Body aspiration needle, single-use FDA UDI
- Device Name
- DISPOSABLE SEMIAUTOMATIC NEEDLE 16G X 100 mm FOR CYTO-HISTOLOGICAL BIOPSY ASPIRATION AS FOR MENGHINI MODIFIED FDA UDI
- Model / Reference
- PC01610 FDA UDI
- Description
- DISPOSABLE SEMIAUTOMATIC NEEDLE 16G X 100 mm FOR CYTO-HISTOLOGICAL BIOPSY ASPIRATION AS FOR MENGHINI MODIFIED FDA UDI
Identifiers
- Catalog Number
- PC01610 FDA UDI
- Primary DI / UDI-DI
- 08056138584884 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
- 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
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Length — 100 Millimeter FDA UDINeedle Gauge — 16 Gauge FDA UDI
Category: Body aspiration needle, single-use
EasyCut by M.d.l. S.r.l. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Body aspiration needle, single-use.
- Arthrex® — Arthrex, Inc. · Class I
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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
K160316 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| 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 (2)
- FDA UDI 0cdc4c51-2000-4b8e-b4fb-0356c3af6a8e 36 fields · synced Jun 20, 2026
- EUDAMED 1 fields · synced Jun 1, 2026