Mark

FDA UDIEUDAMED

Class I (US FDA UDI)

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

Identity

Trade Name: Mark FDA UDI
Generic Name: Radiological image marker, implantable FDA UDI
Device Name: NON-REPOSITIONAL DISPOSABLE NEEDLE 20G x 150 mm FOR MAMMARY NODULE LOCALIZATION, WITH SINGLE HOOK FDA UDI
Model / Reference: PN2015 FDA UDI
Description: NON-REPOSITIONAL DISPOSABLE NEEDLE 20G x 150 mm FOR MAMMARY NODULE LOCALIZATION, WITH SINGLE HOOK FDA UDI

Identifiers

Catalog Number: PN2015 FDA UDI
Primary DI / UDI-DI: 08056138586246 FDA UDI
FDA Product Code: GDF FDA UDI
GMDN Term: Radiological image marker, implantable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

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: Needle Gauge — 20 Gauge FDA UDI
Length — 150 Millimeter FDA UDI

Category: Radiological image marker, implantable

Mark by M.d.l. S.r.l. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

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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 I	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: M.d.l. S.r.l.

Sources (2)

FDA UDI 961eb4ba-f188-47b1-a719-744e022d0948 35 fields · synced Jun 20, 2026
EUDAMED 1 fields · synced Jun 2, 2026