Identity
- Trade Name
- Phoenix Neuro FDA UDI
- Generic Name
- Intracerebral infusion/drainage catheter, long-term FDA UDI
- Device Name
- McComb NN catheter reservoir, intraventricular length = 7 cm FDA UDI
- Model / Reference
- NNCR7 FDA UDI
- Description
- McComb NN catheter reservoir, intraventricular length = 7 cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03760124134438 FDA UDI
- 510(k) Number
- K853362 FDA UDI
- FDA Product Code
- JXG FDA UDI
- GMDN Term
- Intracerebral infusion/drainage catheter, long-term FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5550 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Intracerebral infusion/drainage catheter, long-term
Phoenix Neuro by Sophysa SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intracerebral infusion/drainage catheter, long-term.
- BioGlide® — Medtronic PS Medical · Class II
- Innervision, BioGlide® — Medtronic PS Medical · Class II
- Natus® — Natus Medical Incorporated · Class II
- CODMAN® BACTISEAL® — Integra LifeSciences Production Corporation · Class II
- CODMAN® ACCU-FLO® — Integra LifeSciences Production Corporation · Class II
- Innervision — Medtronic PS Medical · Class II
- CODMAN® HOLTER® — Integra LifeSciences Production Corporation · Class II
- Natus® — Natus Medical Incorporated · Class II
Cleared under the same submission
K853362 also covers:
- Phoenix Neuro — Sophysa SA
- Phoenix Neuro — Sophysa SA
- Phoenix Neuro — Sophysa SA
- Phoenix Neuro — Sophysa SA
- Phoenix Neuro — Sophysa SA
- Phoenix Neuro — Sophysa SA
- Phoenix Neuro — Sophysa SA
- Phoenix Neuro — Sophysa SA
- Phoenix Neuro — Sophysa SA
- Phoenix Neuro — Sophysa SA
- Phoenix Neuro — Sophysa SA
- Phoenix Neuro — Sophysa SA
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
- Sophysa SA
Sources (1)
- FDA UDI c2999292-26c9-484b-bb83-f0f98c00764d 34 fields · synced May 30, 2026