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V-Mark™ Breast Biopsy Site Marker

FDA UDI

Class II (US FDA UDI)

by Argon Medical Devices, Inc.

Identity

Trade Name
V-Mark™ Breast Biopsy Site Marker FDA UDI
Generic Name
Radiological image marker, ingestible FDA UDI
Device Name
V-Mark Breast Biopsy Site Marker with Titanium Anchor For Ultrasound Guidance (15 ga x 18.8 cm) FDA UDI
Model / Reference
15 ga x 18.8 cm FDA UDI
Description
V-Mark Breast Biopsy Site Marker with Titanium Anchor For Ultrasound Guidance (15 ga x 18.8 cm) FDA UDI

Identifiers

Catalog Number
766914180SST FDA UDI
Primary DI / UDI-DI
00886333007172 FDA UDI
510(k) Number
K053518 FDA UDI
FDA Product Code
NEU FDA UDI
GMDN Term
Radiological image marker, ingestible 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

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

Category: Radiological image marker, ingestible

V-Mark™ Breast Biopsy Site Marker by Argon Medical Devices, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiological image marker, ingestible.

Cleared under the same submission

K053518 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Argon Medical Devices, Inc.

Sources (1)

  • FDA UDI e88f22af-f732-4775-99b8-f42a2719ab32 38 fields · synced Jun 9, 2026