Identity
- Trade Name
- BACTISEAL FDA UDI
- Generic Name
- Intracerebral infusion/drainage catheter, short-term FDA UDI
- Device Name
- BEVC BACTISEAL Endoscopic Ventricular Catheter Includes: Ventricular Catheter 14cm (1), Right Angle Adaptor (1), Information manual (1) FDA UDI
- Model / Reference
- 82-3087 FDA UDI
- Description
- BEVC BACTISEAL Endoscopic Ventricular Catheter Includes: Ventricular Catheter 14cm (1), Right Angle Adaptor (1), Information manual (1) FDA UDI
Identifiers
- Catalog Number
- 823087 FDA UDI
- Primary DI / UDI-DI
- 10886704072676 FDA UDI
- 510(k) Number
- K110751 FDA UDI
- FDA Product Code
- JXG FDA UDI
- GMDN Term
- Intracerebral infusion/drainage catheter, short-term FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5550 FDA UDI
- Commercial Distribution
- Not 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
Yes
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
Bactiseal by Cerenovus, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Cerenovus, Inc.
Sources (1)
- FDA UDI b1cbdae1-2969-4c50-8219-352ea6feb763 38 fields · synced May 30, 2026