BiomarC®

FDA UDI

Class II (US FDA UDI)

by Carbon Medical Technologies, Inc.

Identity

Trade Name: BiomarC® FDA UDI
Generic Name: Radiological image marker, implantable FDA UDI
Device Name: Preloaded Barbell Carbon Tissue Marker - Sideport Delivery FDA UDI
Model / Reference: 040236 FDA UDI
Description: Preloaded Barbell Carbon Tissue Marker - Sideport Delivery FDA UDI

Identifiers

Catalog Number: 040236 FDA UDI
Primary DI / UDI-DI: 00858015005240 FDA UDI
FDA Product Code: NEU FDA UDI
GDW FDA UDI
GMDN Term: Radiological image marker, implantable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4300 FDA UDI
878.4750 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 — 4 Millimeter FDA UDI
Outer Diameter — 2 Millimeter FDA UDI

Category: Radiological image marker, implantable

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

Similar devices

Also classified as Radiological image marker, implantable.

UltraClip® Dual Trigger Breast Tissue Marker — Bard Peripheral Vascular · Class II
SenoMark® UltraCor® Breast Tissue Marker — Bard Peripheral Vascular · Class II
Breast localisation needle — Möller Medical GmbH · Class I
Stellar Medical — Stellar Medical, LLC · Class II
SecurMark for ATEC — Hologic, Inc. · Class II
HydroMark — Devicor Medical Products, Inc. · Class II
AutoMark — M.D.L. S.R.L. · Class I
X-Mark Ultra — IZI MEDICAL PRODUCTS LLC · Class II

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Carbon Medical Technologies, Inc.

Sources (1)

FDA UDI 48030a26-1524-408a-9a37-54bbb79780d2 36 fields · synced Jun 9, 2026