Identity
- Trade Name
- Brainlab Flexible Catheter FDA UDI
- Generic Name
- Vascular microcatheter FDA UDI
- Model / Reference
- 19770 FDA UDI
Identifiers
- Catalog Number
- 19770 FDA UDI
- Primary DI / UDI-DI
- 04056481006440 FDA UDI
- 510(k) Number
- K123605 FDA UDI
- FDA Product Code
- HCA FDA UDI
- GMDN Term
- Vascular microcatheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4100 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Brainlab Flexible Catheter by Brainlab SE — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K123605 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
- Brainlab SE
Sources (1)
- FDA UDI 6a12a051-e612-4ce5-86d9-7317422cdd49 36 fields · synced Jun 1, 2026