Tritis 2152SS
GUDID 10884521513907
Graft Dilator
Covidien LP
Meniscus screw| Primary Device ID | 10884521513907 |
| NIH Device Record Key | 623ca4b9-2111-4d05-aa32-3d85f05748af |
| Commercial Distribution Discontinuation | 2019-03-11 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Tritis |
| Version Model Number | 2152SS |
| Catalog Number | 2152SS |
| Company DUNS | 058614483 |
| Company Name | Covidien LP |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| 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
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com |
Device Dimensions
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *; |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10884521513907 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K052810
FDA Product Code
| MBI | FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10884521513907]
Moist Heat or Steam Sterilization
[10884521513907]
Moist Heat or Steam Sterilization
[10884521513907]
Moist Heat or Steam Sterilization
[10884521513907]
Moist Heat or Steam Sterilization
[10884521513907]
Moist Heat or Steam Sterilization
[10884521513907]
Moist Heat or Steam Sterilization
[10884521513907]
Moist Heat or Steam Sterilization
[10884521513907]
Moist Heat or Steam Sterilization
[10884521513907]
Moist Heat or Steam Sterilization
[10884521513907]
Moist Heat or Steam Sterilization
[10884521513907]
Moist Heat or Steam Sterilization
[10884521513907]
Moist Heat or Steam Sterilization
[10884521513907]
Moist Heat or Steam Sterilization
[10884521513907]
Moist Heat or Steam Sterilization
[10884521513907]
Moist Heat or Steam Sterilization
[10884521513907]
Moist Heat or Steam Sterilization
[10884521513907]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2020-04-01 |
| Device Publish Date | 2016-09-24 |
On-Brand Devices [Tritis]
| 10884521514133 | Nitinol Guide Wire |
| 10884521513983 | Tibial Tunnel Length Gauge |
| 10884521513952 | Inserter Stylus |
| 10884521513907 | Graft Dilator |
| 10884521514126 | Non Absorbable ACL Tibial Fixation System |
| 10884521514119 | Non Absorbable ACL Tibial Fixation System |
| 10884521514027 | Fixation Screw Driver |
| 10884521514010 | Implant Removal Tool |
| 10884521514003 | Hand Instrument Removal Tool |
| 10884521513990 | Graft Dilator |
| 10884521513945 | Graft Cleat Inserter |
| 10884521513938 | Inserter Stylus |
| 10884521513921 | Inserter Collet |
| 10884521513914 | Graft Dilator |
| 10884521513891 | Graft Dilator |
| 10884521513884 | Graft Dilator |
| 10884521513877 | ACL Tibial Reconstruction System Kit |
| 10884521514102 | Non Absorbable ACL Tibial Fixation System |
| 10884521514096 | Non Absorbable ACL Tibial Fixation System |
| 10884521514089 | Non Absorbable ACL Tibial Fixation System |
| 10884521514072 | Non Absorbable ACL Tibial Fixation System |
| 10884521514065 | Non Absorbable ACL Tibial Fixation System |
| 10884521514058 | Non Absorbable ACL Tibial Fixation System |
| 10884521514034 | Non Absorbable ACL Tibial Fixation System |
Trademark Results [Tritis]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TRITIS 78689268 3172550 Live/Registered |
COVIDIEN LP 2005-08-10 |
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