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EPstar Fixed Electrophysiology Catheter with Lumen

FDA UDI

Class II (US FDA UDI)

by Baylis Médicale Cie Inc

Identity

Trade Name
EPstar Fixed Electrophysiology Catheter with Lumen FDA UDI
Generic Name
Cardiac mapping catheter, percutaneous, single-use FDA UDI
Device Name
Max guidewire OD 0.035”; 11 electrodes; Electrode spacing: 5-5-5 mm FDA UDI
Model / Reference
DLF-6-10-55-95R FDA UDI
Description
Max guidewire OD 0.035”; 11 electrodes; Electrode spacing: 5-5-5 mm FDA UDI

Identifiers

Catalog Number
N/A FDA UDI
Primary DI / UDI-DI
00685447005995 FDA UDI
FDA Product Code
DRF FDA UDI
GMDN Term
Cardiac mapping catheter, percutaneous, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1220 FDA UDI
Commercial Distribution
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

Dimensions & Sizes

Size
Catheter Gauge — 6 French FDA UDI
Length — 95 Centimeter FDA UDI

Category: Cardiac mapping catheter, percutaneous, single-use

EPstar Fixed Electrophysiology Catheter with Lumen by Baylis Médicale Cie Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac mapping catheter, percutaneous, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Baylis Médicale Cie Inc

Sources (1)

  • FDA UDI 47c0f14b-a9bb-40dc-89ba-3d014f1730f5 35 fields · synced May 31, 2026