Tricera™ Controller R-10001
GUDID 00859273007014
System Controller with Footswitch
RELIGN CORPORATION
Arthroscopic shaver/electrosurgical system generator| Primary Device ID | 00859273007014 |
| NIH Device Record Key | f11e31dc-c335-45f5-ad44-ff419e0941bf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tricera™ Controller |
| Version Model Number | R-10001 |
| Catalog Number | R-10001 |
| Company DUNS | 080031617 |
| Company Name | RELIGN CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00859273007014 [Primary] |
| GS1 | 08592730070016 [Previous] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K162770
FDA Product Code
| HRX | Arthroscope |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
[00859273007014]
Moist Heat or Steam Sterilization
[00859273007014]
Moist Heat or Steam Sterilization
[00859273007014]
Moist Heat or Steam Sterilization
[00859273007014]
Moist Heat or Steam Sterilization
[00859273007014]
Moist Heat or Steam Sterilization
[00859273007014]
Moist Heat or Steam Sterilization
[00859273007014]
Moist Heat or Steam Sterilization
[00859273007014]
Moist Heat or Steam Sterilization
[00859273007014]
Moist Heat or Steam Sterilization
[00859273007014]
Moist Heat or Steam Sterilization
[00859273007014]
Moist Heat or Steam Sterilization
[00859273007014]
Moist Heat or Steam Sterilization
[00859273007014]
Moist Heat or Steam Sterilization
[00859273007014]
Moist Heat or Steam Sterilization
[00859273007014]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-02-28 |
| Device Publish Date | 2020-02-20 |
Devices Manufactured by RELIGN CORPORATION
| 10859273007257 - Curved Standard Ball Burr XL 5.0 mm | 2022-06-24 Standard burr, disposable |
| 10859273007264 - Curved Standard Shaver XL 4.2 mm | 2022-06-24 Standard shaver blade, disposable |
| 10859273007127 - Standard Shaver 3.4mm | 2021-03-15 Standard shaver blade, disposable |
| 10859273007240 - Curved Standard Shaver 3.4mm | 2021-03-15 Standard shaver blade, disposable |
| 00859273007212 - Standard Burr 5.0mm | 2020-10-22 Standard burr, disposable |
| 00859273007236 - Tricera™ Handpiece, Autoclavable | 2020-08-28 Shaver Handpiece, Autoclavable |
| 10859273007080 - 3-in-1 SHAVER™ 4.2mm | 2020-07-27 Multi-functional shaver blade, disposable |
| 00859273007014 - Tricera™ Controller | 2020-02-28System Controller with Footswitch |
| 00859273007014 - Tricera™ Controller | 2020-02-28 System Controller with Footswitch |
Trademark Results [Tricera]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TRICERA 97588746 not registered Live/Pending |
Tianjin Wanda Tyre Group Co., Ltd. 2022-09-13 |
 TRICERA 88058532 not registered Live/Pending |
Relign Corporation 2018-07-30 |
 TRICERA 87263675 5308337 Live/Registered |
Horizon Hobby, LLC 2016-12-09 |
 TRICERA 74095049 1676460 Dead/Cancelled |
Technical Service Teams, Inc. 1990-09-10 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.