Kopans

FDA UDI

Class I (US FDA UDI)

by Cook Incorporated

Identity

Trade Name: Kopans FDA UDI
Generic Name: Radiological image marker, implantable FDA UDI
Device Name: Kopans Breast Lesion Localization Needle Inconel FDA UDI
Model / Reference: G26976 FDA UDI
Description: Kopans Breast Lesion Localization Needle Inconel FDA UDI

Identifiers

Catalog Number: IDKBL-20-7.0-A FDA UDI
Primary DI / UDI-DI: 00827002269767 FDA UDI
FDA Product Code: MIJ FDA UDI
GMDN Term: Radiological image marker, implantable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Radiological image marker, implantable

Kopans by Cook Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Radiological image marker, implantable.

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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 I	Pending data

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Manufacturer

Manufacturer: Cook Incorporated

Sources (1)

FDA UDI d59f0863-9ed9-4fb9-b21a-d62e85f5be2b 36 fields · synced Jun 8, 2026