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Freezor®

FDA UDI

Class III (US FDA UDI)

by Medtronic, Inc.

Identity

Trade Name
Freezor® FDA UDI
Generic Name
Cardiac cryosurgical system catheter FDA UDI
Device Name
CATHETER 307F3 FREEZOR3 MED BLUE 7F FDA UDI
Model / Reference
307F3 FDA UDI
Description
CATHETER 307F3 FREEZOR3 MED BLUE 7F FDA UDI

Identifiers

Primary DI / UDI-DI
00643169504752 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
Length — 108.0 Centimeter FDA UDI

Category: Cardiac cryosurgical system catheter

Freezor® 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 5d786516-af58-4efd-b53e-49f8491ad2b4 37 fields · synced May 30, 2026