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Medline

FDA UDI

Class II (US FDA UDI)

by Medline Industries, Inc.

Identity

Trade Name
MEDLINE FDA UDI
Generic Name
Cardiac mapping catheter, percutaneous, reprocessed FDA UDI
Device Name
BW DEFLECTABLE CATH D CURV 8POLE 282 5FR FDA UDI
Model / Reference
D508DP10RTRH FDA UDI
Description
BW DEFLECTABLE CATH D CURV 8POLE 282 5FR FDA UDI

Identifiers

Catalog Number
D508DP10RTRH FDA UDI
Primary DI / UDI-DI
10197344157334 FDA UDI
510(k) Number
K241224 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Cardiac mapping catheter, percutaneous, reprocessed

Medline by Medline Industries, Inc. — 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

K241224 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medline Industries, Inc.

Sources (1)

  • FDA UDI 862cfbc8-68e3-49aa-8e94-2fee9d726d64 36 fields · synced May 30, 2026