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Profile 3D™ 680R26

by Medtronic, Inc. 3 variants

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number00613994410344 UDI-DI Date18 Jun 2015ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Profile 3D™
Generic Name
Mitral annuloplasty ring
Model / Reference
680R26
Primary DI / UDI-DI
00613994410344
510(k) Number
FDA Product Code
KRH
GMDN Term
Mitral annuloplasty ring
Device Class
Class II
Regulation Number
870.3800
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Conditional
Size
Lumen/Inner Diameter — 26.0 Millimeter

Related devices

Cleared under the same submission (K073324)

Show all (12)

Other devices from Medtronic, Inc.

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Serial Number

Other properties (10)

  • 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