MammoStar™

FDA UDI

Class II (US FDA UDI)

by Carbon Medical Technologies, Inc.

Identity

Trade Name: MammoStar™ FDA UDI
Generic Name: Radiological image marker, implantable FDA UDI
Device Name: Biopsy Site Identifier FDA UDI
Model / Reference: STAR1102 FDA UDI
Description: Biopsy Site Identifier FDA UDI

Identifiers

Catalog Number: STAR1102 FDA UDI
Primary DI / UDI-DI: 00858015005400 FDA UDI
FDA Product Code: NEU FDA UDI
GMDN Term: Radiological image marker, implantable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4300 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Dimensions & Sizes

Size: Length — 17 Millimeter FDA UDI
Outer Diameter — 2 Millimeter FDA UDI

Category: Radiological image marker, implantable

MammoStar™ by Carbon Medical Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Carbon Medical Technologies, Inc.

Sources (1)

FDA UDI b1d89be8-4643-4d6b-bbd2-e3a8c4074ca6 37 fields · synced Jun 9, 2026