Identity
- Trade Name
- ShuntPen Cannula FDA UDI
- Generic Name
- Neuroscopic shunt placement kit FDA UDI
- Device Name
- ShuntPen Cannula, to be used with Clarus 3000N Flexible Fiberoptic Endoscope. FDA UDI
- Model / Reference
- 2120C FDA UDI
- Description
- ShuntPen Cannula, to be used with Clarus 3000N Flexible Fiberoptic Endoscope. FDA UDI
Identifiers
- Catalog Number
- 2120C FDA UDI
- Primary DI / UDI-DI
- B0672120C1 FDA UDI
- 510(k) Number
- K942249 FDA UDI
- FDA Product Code
- GWG FDA UDI
- GMDN Term
- Neuroscopic shunt placement kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1480 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Neuroscopic shunt placement kit
ShuntPen Cannula by Clarus Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Neuroscopic shunt placement kit.
- Innervision, BioGlide® — Medtronic PS Medical · Class II
- Innervision — Medtronic PS Medical · Class II
- Innervision — Medtronic PS Medical · Class II
Cleared under the same submission
K942249 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 |
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Manufacturer
- Manufacturer
- Clarus Medical, Llc
Sources (1)
- FDA UDI 6a3a5f09-0a83-4ec6-9ef9-00ff2421fe99 36 fields · synced May 30, 2026