← Back to catalogue

Biosense Webster

FDA UDI

Class II (US FDA UDI)

by Stryker Sustainability Solutions

Identity

Trade Name
Biosense Webster FDA UDI
Generic Name
Cardiac mapping catheter, percutaneous, reprocessed FDA UDI
Device Name
Diagnostic EP Catheter ISMUS, 7F FDA UDI
Model / Reference
D7R20P14CT FDA UDI
Description
Diagnostic EP Catheter ISMUS, 7F FDA UDI

Identifiers

Catalog Number
D7R20P14CT FDA UDI
Primary DI / UDI-DI
07613327359923 FDA UDI
510(k) Number
K012708 FDA UDI
FDA Product Code
NLH FDA UDI
GMDN Term
Cardiac mapping catheter, percutaneous, reprocessed 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Length — 110.0 Centimeter FDA UDI

Category: Cardiac mapping catheter, percutaneous, reprocessed

Biosense Webster by Stryker Sustainability Solutions — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac mapping catheter, percutaneous, reprocessed.

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
Stryker Sustainability Solutions

Sources (1)

  • FDA UDI 379d1743-7b07-4194-94a5-7593195ee702 37 fields · synced Jun 8, 2026