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Freezor® Xtra

FDA UDI

Class III (US FDA UDI)

by Medtronic, Inc.

Identity

Trade Name
Freezor® Xtra FDA UDI
Generic Name
Cardiac cryosurgical system catheter FDA UDI
Device Name
CATHETER 227F1 FREEZOR XTRA1 SH 7F FDA UDI
Model / Reference
227F1 FDA UDI
Description
CATHETER 227F1 FREEZOR XTRA1 SH 7F FDA UDI

Identifiers

Primary DI / UDI-DI
00643169672468 FDA UDI
PMA Number
P020045 FDA UDI
FDA Product Code
LPB FDA UDI
GMDN Term
Cardiac cryosurgical system catheter FDA UDI

Classification

Device Class
Class III 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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Catheter Gauge — 7.0 French FDA UDI
Length — 108.0 Centimeter FDA UDI

Category: Cardiac cryosurgical system catheter

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

Similar devices

Also classified as Cardiac cryosurgical system catheter.

Cleared under the same submission

P020045 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 dd1f7846-1eb7-4197-b624-5000c965f0d4 37 fields · synced Jun 8, 2026