Identity
- Trade Name
- SmartFlow FDA UDI
- Generic Name
- Intracerebral cannula, nonimplantable, single-use FDA UDI
- Device Name
- SmartFlow Neuro Cannula, 16 ga, .008" ID x 10 ft x 18mm tip FDA UDI
- Model / Reference
- NGS-NC-02-EE FDA UDI
- Description
- SmartFlow Neuro Cannula, 16 ga, .008" ID x 10 ft x 18mm tip FDA UDI
Identifiers
- Catalog Number
- NGS-NC-02-EE FDA UDI
- Primary DI / UDI-DI
- 00850047354112 FDA UDI
- 510(k) Number
- DEN240023 FDA UDI
- FDA Product Code
- SDG FDA UDI
- GMDN Term
- Intracerebral cannula, nonimplantable, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4110 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Intracerebral cannula, nonimplantable, single-use
SmartFlow by Clearpoint Neuro, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
DEN240023 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Clearpoint Neuro, Inc.
Sources (1)
- FDA UDI 8b5ccadd-c42f-4245-82e8-c897d67140bb 36 fields · synced Jun 8, 2026