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N/A 1056167

by Medtronic Xomed, Inc.

Listed FDA GUDID listing, no authorization on record

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 Number00763000039554 UDI-DI Date23 Apr 2020ListedStatusListed GUDID: 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  • Withdrawn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
1056167
Primary DI / UDI-DI
00763000039554
510(k) Number
FDA Product Code
ETD
GMDN Term
Tympanostomy tube
Device Class
Class II
Regulation Number
874.3880
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional
Size
Lumen/Inner Diameter — 1.14 Millimeter
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