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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
Model / Reference
D134904 FDA UDI

Identifiers

Catalog Number
D134904 FDA UDI
Primary DI / UDI-DI
07613327361988 FDA UDI
510(k) Number
K112292 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 — 115.0 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.

Cleared under the same submission

K112292 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Stryker Sustainability Solutions

Sources (1)

  • FDA UDI 0d5abe65-6a3c-4642-a245-3ac922a70a0b 36 fields · synced May 30, 2026