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Cardiotronic

FDA UDI

Class II (US FDA UDI)

by Osypka Medical, Inc.

Identity

Trade Name
CARDIOTRONIC FDA UDI
Generic Name
External pacemaker, epicardial pacing FDA UDI
Device Name
PACE 101 External Single-Chamber Pacemaker (with clamping terminals) FDA UDI
Model / Reference
PACE 101 FDA UDI
Description
PACE 101 External Single-Chamber Pacemaker (with clamping terminals) FDA UDI

Identifiers

Catalog Number
2001 FDA UDI
Primary DI / UDI-DI
04260451441012 FDA UDI
510(k) Number
K033130 FDA UDI
FDA Product Code
DTE FDA UDI
GMDN Term
External pacemaker, epicardial pacing FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.3600 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: External pacemaker, epicardial pacing

Cardiotronic by Osypka Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as External pacemaker, epicardial pacing.

Cleared under the same submission

K033130 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Osypka Medical, Inc.

Sources (1)

  • FDA UDI 4d44fbf0-6a32-412a-9170-004fd2ffcc1e 37 fields · synced May 30, 2026