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Sinurep

FDA UDI

Class I (US FDA UDI)

by Medax Unipersonale Srl

Identity

Trade Name
SINUREP FDA UDI
Generic Name
Imaging lesion localization marker, external, single-use FDA UDI
Device Name
Breast localization needle 20G X 100 MM FDA UDI
Model / Reference
SR20100-00 FDA UDI
Description
Breast localization needle 20G X 100 MM FDA UDI

Identifiers

Primary DI / UDI-DI
08056515888093 FDA UDI
FDA Product Code
MIJ FDA UDI
GMDN Term
Imaging lesion localization marker, external, single-use 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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Imaging lesion localization marker, external, single-use

Sinurep by Medax Unipersonale Srl — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Imaging lesion localization marker, external, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medax Unipersonale Srl

Sources (1)

  • FDA UDI 90093953-4bb7-4305-a5ca-59b572ec1705 33 fields · synced May 30, 2026