Spires
GUDID 20681490195595
VENT TUBE 9128033 100PK SPIRES GROM PAIR
MEDTRONIC XOMED, INC.
Tympanostomy tube| Primary Device ID | 20681490195595 |
| NIH Device Record Key | efd6313c-1dff-40cb-bdad-5da09902183d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Spires |
| Version Model Number | 9128033 |
| Company DUNS | 835465063 |
| Company Name | MEDTRONIC XOMED, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00681490195591 [Primary] |
| GS1 | 20681490195595 [Package] Contains: 00681490195591 Package: PK [100 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K151067
FDA Product Code
| ETD | TUBE, TYMPANOSTOMY |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2015-07-13 |
Devices Manufactured by MEDTRONIC XOMED, INC.
| 00763000892951 - M4 | 2026-03-09 MICRODEBRIDER 1898200T IGS M4 ROHS |
| 00199150023851 - N/A | 2026-02-24 PROBE 8225101E PRASS STD PROT HANDLE |
| 00199150023868 - N/A | 2026-02-24 PROBE 8225101 5PK PRASS STD PROT HANDLE |
| 00199150023875 - N/A | 2026-02-24 PROBE 8225110 10PK PRASS STD |
| 00199150023882 - N/A | 2026-02-24 PROBE 8225103 5PK PRASS SLIM PROT HANDLE |
| 00763000548797 - Hydrodebrider | 2026-02-23 HYDRODEBRIDER 1914001 STD HANDPIECE ROHS |
| 00763000548803 - Hydrodebrider | 2026-02-23 HANDPIECE 1921002 HYDRODEBRID FRNTL ROHS |
| 20763000888910 - Merocel | 2026-02-23 PACKING 400151 100PK MICRO SPHERES 4MM |
Trademark Results [Spires]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SPIRES 88407015 not registered Live/Pending |
EarthQuaker Devices, LLC 2019-04-29 |
 SPIRES 85151670 not registered Dead/Abandoned |
University of Saint Mary, Inc. 2010-10-13 |
 SPIRES 76568542 2910238 Dead/Cancelled |
SPIRÃS RESTAURANTS, INC. 2003-12-22 |
 SPIRES 75725796 2554593 Dead/Cancelled |
Pinnacle Global Group, Inc. 1999-06-09 |
 SPIRES 75722891 2562786 Dead/Cancelled |
Pinnacle Global Group, Inc. 1999-06-07 |
 SPIRES 75714174 not registered Dead/Abandoned |
Merrill Lynch & Co., Inc. 1999-05-18 |
 SPIRES 73465934 1361505 Dead/Cancelled |
BOARD OF TRUSTEES OF LELAND STANFORD JUNIOR UNIVERSITY, THE 1984-02-16 |
 SPIRES 73205025 1141219 Dead/Cancelled |
Spires Management Incorporated 1979-02-26 |
 SPIRES 72400814 0950998 Dead/Expired |
SPIRES MANAGEMENT INC. 1971-08-23 |
© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.