← Back to catalogue

NaviStar

FDA UDI

Class II (US FDA UDI)

by Biosense Webster Inc

Identity

Trade Name
NaviStar FDA UDI
Generic Name
Cardiac radio-frequency ablation system catheter FDA UDI
Model / Reference
118434S FDA UDI

Identifiers

Catalog Number
118434S FDA UDI
Primary DI / UDI-DI
10846835001983 FDA UDI
PMA Number
P990025 FDA UDI
FDA Product Code
DRF FDA UDI
GMDN Term
Cardiac radio-frequency ablation system catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1220 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

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

NaviStar by Biosense Webster Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

P990025 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Biosense Webster Inc

Sources (1)

  • FDA UDI bab9ab47-786e-4947-a249-008ada6d3a83 37 fields · synced May 30, 2026