C-Flex®
GUDID 20763000282800
VENT TUBE 1066039 10PK POPE TAIL PR 1.14
MEDTRONIC XOMED, INC.
Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube| Primary Device ID | 20763000282800 |
| NIH Device Record Key | 7fff9078-a243-4472-9e84-a525d0cd0b04 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | C-Flex® |
| Version Model Number | 1066039 |
| 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 |
| Lumen/Inner Diameter | 1.14 Millimeter |
| Lumen/Inner Diameter | 1.14 Millimeter |
| Lumen/Inner Diameter | 1.14 Millimeter |
| Lumen/Inner Diameter | 1.14 Millimeter |
| Lumen/Inner Diameter | 1.14 Millimeter |
| Lumen/Inner Diameter | 1.14 Millimeter |
| Lumen/Inner Diameter | 1.14 Millimeter |
| Lumen/Inner Diameter | 1.14 Millimeter |
| Lumen/Inner Diameter | 1.14 Millimeter |
| Lumen/Inner Diameter | 1.14 Millimeter |
| Lumen/Inner Diameter | 1.14 Millimeter |
| Lumen/Inner Diameter | 1.14 Millimeter |
| Lumen/Inner Diameter | 1.14 Millimeter |
| Lumen/Inner Diameter | 1.14 Millimeter |
| Lumen/Inner Diameter | 1.14 Millimeter |
| Lumen/Inner Diameter | 1.14 Millimeter |
| Lumen/Inner Diameter | 1.14 Millimeter |
| Lumen/Inner Diameter | 1.14 Millimeter |
| Lumen/Inner Diameter | 1.14 Millimeter |
| Lumen/Inner Diameter | 1.14 Millimeter |
| Lumen/Inner Diameter | 1.14 Millimeter |
| Lumen/Inner Diameter | 1.14 Millimeter |
| Lumen/Inner Diameter | 1.14 Millimeter |
| Lumen/Inner Diameter | 1.14 Millimeter |
| Lumen/Inner Diameter | 1.14 Millimeter |
| Lumen/Inner Diameter | 1.14 Millimeter |
| Lumen/Inner Diameter | 1.14 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000282806 [Primary] |
| GS1 | 20763000282800 [Package] Contains: 00763000282806 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 [C-Flex®]
| 00681490041928 | SPLINT 1524075 DOYLE BIVALVE SET C-FLEX |
| 20763000282916 | VENT TUBE 1076032 50PK ARMSTNG BEV GROM |
| 20763000282800 | VENT TUBE 1066039 10PK POPE TAIL PR 1.14 |
| 20763000282794 | VENT TUBE 1066037 10PK PAIR COLLAR BUTT |
| 20763000282787 | VENT TUBE 1066036 10PK POPE TYPE PR 1.14 |
| 20763000282770 | VENT TUBE 1066033 10PK ARMSTNG V GROM PR |
| 20763000282763 | VENT TUBE 1066032 10PK ARMST GRM PR 1.14 |
| 20763000282749 | VENT TUBE 1066012 10PK TUOMA T GROM PAIR |
| 20763000282732 | VENT TUBE 1066005 10PK PAPA PAIRS 1.02MM |
| 20763000282725 | VENT TUBE 1056705 5PK MORETZ TAB |
| 20763000282480 | VENT TUBE 1056037 5PK COLLAR BUTTON 1.27 |
| 20763000282473 | VENT TUBE 1056033 5PK ARMSTR V GROMMET |
| 20763000282466 | VENT TUBE 1056032 5PK ARMSTRNG BEV GROM |
| 20763000282459 | VENT TUBE 1056031 5PK ARMSTRG V 1.14X4.5 |
| 20763000282435 | VENT TUBE 1056018 5PK T TUBE 1.14MM |
| 20763000282404 | VENT TUBE 1056012 5PK TOUMA T GROMMET |
| 20763000282398 | VENT TUBE 1056010 5PK DONALDSON 1.14MM |
| 20763000282381 | VENT TUBE 1056005 5PK PAPA W/TAB 1.02 |
| 20763000281858 | VENT TUBE 1002341 5PK V-T 1.27 C-FLEX |
| 00763000035679 | SPLINT 1524075 DOYLE BIVALVE SET C-FLEX |
Trademark Results [C-Flex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 C-FLEX 90004192 not registered Live/Pending |
TADD, LLC 2020-06-16 |
 C-FLEX 88207391 not registered Live/Pending |
The Nielsen Company (US), LLC 2018-11-27 |
 C-FLEX 87480394 5807409 Live/Registered |
HÃBNER GmbH & Co. KG 2017-06-08 |
 C-FLEX 86657802 not registered Dead/Abandoned |
Carolina Cap Company 2015-06-10 |
 C-FLEX 86306725 4671430 Live/Registered |
Saint-Gobain Performance Plastics Corporation 2014-06-11 |
 C-FLEX 85202859 3997488 Live/Registered |
Allen Medical Systems, Inc. 2010-12-21 |
 C-FLEX 81014707 1014707 Dead/Cancelled |
Seeman Plastics, Incorporated 0000-00-00 |
 C-FLEX 79379766 not registered Live/Pending |
SAFILO - Societa Azionaria Fabbrica Italiana Lavorazione Occhiali S.p.A. 2023-07-10 |
 C-FLEX 78810285 3715311 Live/Registered |
Rayner Intraocular Lenses Limited 2006-02-08 |
 C-FLEX 77675146 4060387 Live/Registered |
Pan-Oston Co. 2009-02-20 |
 C-FLEX 77124230 3931252 Dead/Cancelled |
Colortronic Systems AG 2007-03-07 |
 C-FLEX 77062166 3274079 Live/Registered |
Caravan Beads, Inc. 2006-12-12 |
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