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Na 106A3

by Medtronic, Inc. 8 variants

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

2 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00613994775955 UDI-DI Date23 Sep 2014ListedStatusListed GUDID: not in commercial distribution

Recalls

2 recalls · FDA

    • Terminated Z-2777-2015 FDA Class II initiated 1 Sep 2015

    An issue with a USB memory component contained within a subset of CryoConsoles can result in extended procedure time.

    • Terminated Z-1452-06 FDA Unclassified (pre-2012) initiated 4 Aug 2006

    Outer cartons of catheters were mislabeled with two different reference numbers. The front of the package showed the correct reference number; 207F1, however the section on the top of the box incorrectly referenced 207F3. All inside labels (inside the box and affixed on device pouches) showed the correct reference number, 207F1.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Cardiac cryosurgical system
Model / Reference
106A3
Primary DI / UDI-DI
00613994775955
PMA Number
FDA Product Code
LPB, BRT, BRW
GMDN Term
Cardiac cryosurgical system
Device Class
Class III
Regulation Number
880.6760, 868.5820
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (P020045)

Show all (12)

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Properties

  • Prescription Use
  • Serial Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No