EasyCut

FDA UDI

Class II (US FDA UDI)

by M.d.l. S.r.l.

Identity

Trade Name: EasyCut FDA UDI
Generic Name: Body aspiration needle, single-use FDA UDI
Device Name: DISPOSABLE SEMIAUTOMATIC NEEDLE 20G X 200 mm FOR CYTO-HISTOLOGICAL BIOPSY ASPIRATION AS FOR MENGHINI MODIFIED FDA UDI
Model / Reference: PC02020 FDA UDI
Description: DISPOSABLE SEMIAUTOMATIC NEEDLE 20G X 200 mm FOR CYTO-HISTOLOGICAL BIOPSY ASPIRATION AS FOR MENGHINI MODIFIED FDA UDI

Identifiers

Catalog Number: PC02020 FDA UDI
Primary DI / UDI-DI: 08056138584907 FDA UDI
510(k) Number: K160316 FDA UDI
FDA Product Code: FCG FDA UDI
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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Length — 200 Millimeter FDA UDI
Needle Gauge — 20 Gauge FDA UDI

Category: Body aspiration needle, single-use

EasyCut by M.d.l. S.r.l. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Body aspiration needle, single-use.

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ECOJEKT — H.S. HOSPITAL SERVICE SPA · Class I
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Echotip — COOK INCORPORATED · Class I
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 (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 0762355f-8181-436c-867a-426b0eb7bd6a 36 fields · synced May 30, 2026