Identity
- Trade Name
- Kopans FDA UDI
- Generic Name
- Radiological image marker, implantable FDA UDI
- Device Name
- Kopans Breast Lesion Localization Needle With Echotip FDA UDI
- Model / Reference
- G04343 FDA UDI
- Description
- Kopans Breast Lesion Localization Needle With Echotip FDA UDI
Identifiers
- Catalog Number
- DKBL-20-5.0-A-U FDA UDI
- Primary DI / UDI-DI
- 00827002043435 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Radiological image marker, implantable
Kopans by Cook Incorporated — Class I — 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cook Incorporated
Sources (1)
- FDA UDI 9bf99dea-ac7d-4e12-a55b-dca8760d08ed 36 fields · synced Jun 8, 2026