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Na 1019301

by Medtronic Xomed, Inc.

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 Number00613994176653 UDI-DI Date7 Jul 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  • Withdrawn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

Generic Name
Tympanostomy tube
Model / Reference
1019301
Primary DI / UDI-DI
00613994176653
510(k) Number
FDA Product Code
ETD
GMDN Term
Tympanostomy tube
Device Class
Class II
Regulation Number
874.3880
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Conditional
Size
Length — 7.0 Millimeter

Related devices

Category: Tympanostomy tube

Cleared under the same submission (K151067)

Show all (12)

Other devices from Medtronic Xomed, Inc.

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number

Other properties (9)

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