Identity
- Trade Name
- DKBL-20-7.0-A-U FDA UDI
- Generic Name
- Imaging lesion localization marker, external, single-use FDA UDI
- Model / Reference
- G09984 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815212024184 FDA UDI
- FDA Product Code
- MIJ FDA UDI
- GMDN Term
- Imaging lesion localization marker, external, single-use 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
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Category: Imaging lesion localization marker, external, single-use
Dkbl-20-7.0-A-U by Izi Medical Products Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Imaging lesion localization marker, external, single-use.
- MEDWIRE — Medax Unipersonale Srl · Class I
- Xact — Solstice Corp. · Class I
- REAL INTELLIGENCE — Smith & Nephew, Inc. · Class II
- SINUREP — Medax Unipersonale Srl · Class I
- MEDWIRE — Medax Unipersonale Srl · Class I
- 7D Surgical FLASH Frame — 7D Surgical ULC · Class II
- MEDWIRE — Medax Unipersonale Srl · Class I
- NDI Passive Spheres — Northern Digital Inc · 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
- Izi Medical Products Llc
Sources (1)
- FDA UDI eba08afd-9de8-4fb2-a6bc-1c1196b0e097 32 fields · synced Jun 6, 2026