Identity
- Trade Name
- SmartClip FDA UDI
- Generic Name
- Radiological image marker, implantable FDA UDI
- Device Name
- Soft tissue marker and delivery system - Pink, 10cm FDA UDI
- Model / Reference
- SMARTCLIP LITE, PINK, 10CM FDA UDI
- Description
- Soft tissue marker and delivery system - Pink, 10cm FDA UDI
Identifiers
- Catalog Number
- SMARTCLIPLT-PNK-10 FDA UDI
- Primary DI / UDI-DI
- 10851674008161 FDA UDI
- 510(k) Number
- K180640 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
- Not 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
SmartClip by Elucent Medical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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
- Elucent Medical Inc.
Sources (1)
- FDA UDI 5bb0e305-33e7-43cd-91de-c375046cf5e2 38 fields · synced May 30, 2026