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Dlp®

FDA UDI

Class I (US FDA UDI)

by Medtronic, Inc.

Identity

Trade Name
DLP® FDA UDI
Generic Name
Cardiac insulation pad FDA UDI
Device Name
PAD 38003 PHRENIC NERVE LARGE 10P 17L FDA UDI
Model / Reference
38003 FDA UDI
Description
PAD 38003 PHRENIC NERVE LARGE 10P 17L FDA UDI

Identifiers

Primary DI / UDI-DI
20613994844884 FDA UDI
510(k) Number
K890707 FDA UDI
FDA Product Code
DWS FDA UDI
GMDN Term
Cardiac insulation pad FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
870.4500 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

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Cardiac insulation pad

Dlp® by Medtronic, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac insulation pad.

Cleared under the same submission

K890707 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtronic, Inc.

Sources (1)

  • FDA UDI 79adf36c-b1ce-4a57-8461-63d902657506 35 fields · synced May 30, 2026