C-Flex®
GUDID 20763000282916
VENT TUBE 1076032 50PK ARMSTNG BEV GROM
MEDTRONIC XOMED, INC.
Tympanostomy tube| Primary Device ID | 20763000282916 |
| NIH Device Record Key | 0d203d1f-0c65-42d8-bbf6-e73e0c482a6f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | C-Flex® |
| Version Model Number | 1076032 |
| 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 | 00763000282912 [Primary] |
| GS1 | 20763000282916 [Package] Contains: 00763000282912 Package: PK [50 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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