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CapSureFix Novus MRI™ SureScan® 5076-58

by Medtronic, Inc. GUDID

Listed FDA GUDID listing, not in commercial distribution

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00643169448902 UDI-DIDate20 Oct 2014ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

GUDID

Trade Name
CapSureFix Novus MRI™ SureScan®
Generic Name
Endocardial/interventricular septal pacing lead
Model / Reference
5076-58
Primary DI / UDI-DI
00643169448902
PMA Number
FDA Product Code
NVN, DTB, NVY
GMDN Term
Endocardial/interventricular septal pacing lead
Device Class
Class III
Regulation Number
870.3680
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Conditional
Size
Length — 58.0 Centimeter

Related devices

Cleared under the same submission (P930039)

Show all (12)

Other devices from Medtronic, Inc.

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Combination Product
  • Serial Number

Other properties (8)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No