BioZorb

FDA UDI

Class II (US FDA UDI)

by Hologic, Inc.

Identity

Trade Name: BioZorb FDA UDI
Generic Name: Radiological image marker, implantable FDA UDI
Device Name: BioZorb Marker FDA UDI
Model / Reference: F0404 FDA UDI
Description: BioZorb Marker FDA UDI

Identifiers

Catalog Number: F0404 FDA UDI
Primary DI / UDI-DI: 15420045514058 FDA UDI
510(k) Number: K143484 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 Conditional FDA UDI

Category: Radiological image marker, implantable

BioZorb by Hologic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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RepoMark — M.D.L. S.R.L. · Class I

Cleared under the same submission

K143484 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: Hologic, Inc.

Sources (1)

FDA UDI 0caa6cb6-86fe-4add-b0c4-8180bd82b889 36 fields · synced Jun 8, 2026