Carbon Bright®

FDA UDI

Class II (US FDA UDI)

by Carbon Medical Technologies, Inc.

Identity

Trade Name: Carbon Bright® FDA UDI
Generic Name: Radiological image marker, implantable FDA UDI
Device Name: Fiducial Marker System FDA UDI
Model / Reference: 040152 FDA UDI
Description: Fiducial Marker System FDA UDI

Identifiers

Catalog Number: 040152 FDA UDI
Primary DI / UDI-DI: 00850002461053 FDA UDI
510(k) Number: K132064 FDA UDI
FDA Product Code: IYE FDA UDI
GMDN Term: Radiological image marker, implantable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.5050 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 Conditional FDA UDI

Dimensions & Sizes

Size: Length — 5 Millimeter FDA UDI
Outer Diameter — 1 Millimeter FDA UDI
Length — 20 Centimeter FDA UDI
Needle Gauge — 18 Gauge FDA UDI

Category: Radiological image marker, implantable

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

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Cleared under the same submission

K132064 also covers:

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 e9fed457-46a1-4597-b63d-baf5d06561d0 37 fields · synced Jun 9, 2026