← Back to catalogue

Capsure® EPI

FDA UDI

Class III (US FDA UDI)

by Medtronic, Inc.

Identity

Trade Name
Capsure® EPI FDA UDI
Generic Name
Epicardial pacing lead FDA UDI
Device Name
LEAD 4965-35 US UNI EPI STERD 35CM FDA UDI
Model / Reference
4965-35 FDA UDI
Description
LEAD 4965-35 US UNI EPI STERD 35CM FDA UDI

Identifiers

Primary DI / UDI-DI
00613994501776 FDA UDI
PMA Number
P950024 FDA UDI
FDA Product Code
DTB FDA UDI
NVY FDA UDI
NVN FDA UDI
GMDN Term
Epicardial pacing lead FDA UDI

Classification

Device Class
Class III FDA UDI
Regulation Number
870.3680 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 35.0 Centimeter FDA UDI

Category: Epicardial pacing lead

Capsure® EPI by Medtronic, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Epicardial pacing lead.

Cleared under the same submission

P950024 also covers:

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
Medtronic, Inc.

Sources (1)

  • FDA UDI 0192c0de-3afa-482c-bcf9-b360e83a0a34 37 fields · synced May 30, 2026