T-Tube® C-Flex®
GUDID 20763000282756
VENT TUBE 1066016 10PK PAIR T TUBE 1.14
MEDTRONIC XOMED, INC.
Tympanostomy tube| Primary Device ID | 20763000282756 |
| NIH Device Record Key | 57338897-709d-450f-9391-dff33d1df2d2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | T-Tube® C-Flex® |
| Version Model Number | 1066016 |
| Company DUNS | 835465063 |
| Company Name | MEDTRONIC XOMED, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| 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
| Lumen/Inner Diameter | 1.14 Millimeter |
| Length | 6 Millimeter |
| Lumen/Inner Diameter | 1.14 Millimeter |
| Length | 6 Millimeter |
| Lumen/Inner Diameter | 1.14 Millimeter |
| Length | 6 Millimeter |
| Lumen/Inner Diameter | 1.14 Millimeter |
| Length | 6 Millimeter |
| Lumen/Inner Diameter | 1.14 Millimeter |
| Length | 6 Millimeter |
| Lumen/Inner Diameter | 1.14 Millimeter |
| Length | 6 Millimeter |
| Lumen/Inner Diameter | 1.14 Millimeter |
| Length | 6 Millimeter |
| Lumen/Inner Diameter | 1.14 Millimeter |
| Length | 6 Millimeter |
| Lumen/Inner Diameter | 1.14 Millimeter |
| Length | 6 Millimeter |
| Lumen/Inner Diameter | 1.14 Millimeter |
| Length | 6 Millimeter |
| Lumen/Inner Diameter | 1.14 Millimeter |
| Length | 6 Millimeter |
| Lumen/Inner Diameter | 1.14 Millimeter |
| Length | 6 Millimeter |
| Lumen/Inner Diameter | 1.14 Millimeter |
| Length | 6 Millimeter |
| Lumen/Inner Diameter | 1.14 Millimeter |
| Length | 6 Millimeter |
| Lumen/Inner Diameter | 1.14 Millimeter |
| Length | 6 Millimeter |
| Lumen/Inner Diameter | 1.14 Millimeter |
| Length | 6 Millimeter |
| Lumen/Inner Diameter | 1.14 Millimeter |
| Length | 6 Millimeter |
| Lumen/Inner Diameter | 1.14 Millimeter |
| Length | 6 Millimeter |
| Lumen/Inner Diameter | 1.14 Millimeter |
| Length | 6 Millimeter |
| Lumen/Inner Diameter | 1.14 Millimeter |
| Length | 6 Millimeter |
| Lumen/Inner Diameter | 1.14 Millimeter |
| Length | 6 Millimeter |
| Lumen/Inner Diameter | 1.14 Millimeter |
| Length | 6 Millimeter |
| Lumen/Inner Diameter | 1.14 Millimeter |
| Length | 6 Millimeter |
| Lumen/Inner Diameter | 1.14 Millimeter |
| Length | 6 Millimeter |
| Lumen/Inner Diameter | 1.14 Millimeter |
| Length | 6 Millimeter |
| Lumen/Inner Diameter | 1.14 Millimeter |
| Length | 6 Millimeter |
| Lumen/Inner Diameter | 1.14 Millimeter |
| Length | 6 Millimeter |
| Lumen/Inner Diameter | 1.14 Millimeter |
| Length | 6 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000282752 [Primary] |
| GS1 | 20763000282756 [Package] Contains: 00763000282752 Package: PK [10 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 | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-12-25 |
| Device Publish Date | 2020-12-17 |
On-Brand Devices [T-Tube® C-Flex®]
| 20763000282756 | VENT TUBE 1066016 10PK PAIR T TUBE 1.14 |
| 20763000282442 | VENT TUBE 1056019 5PK T TUBE 1.14MM |
| 20763000282428 | VENT TUBE 1056016 5PK T TUBE 1.14MM |
| 20763000282411 | VENT TUBE 1056015 5PK T TUBE 1.14 C-FLEX |
Trademark Results [T-Tube]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 T-TUBE 78889800 3464351 Dead/Cancelled |
UFP Technologies, Inc. 2006-05-23 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.