| Primary Device ID | 00811714035338 |
| NIH Device Record Key | 1e64c8b4-113c-4300-8c75-27ebc65d1c16 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Thunderbolt |
| Version Model Number | 909010-0000 |
| Company DUNS | 002745858 |
| Company Name | RESPONSIVE ORTHOPEDICS LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00811714035338 [Primary] |
| FSM | Tray, Surgical, Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00811714035338]
Moist Heat or Steam Sterilization
[00811714035338]
Moist Heat or Steam Sterilization
[00811714035338]
Moist Heat or Steam Sterilization
[00811714035338]
Moist Heat or Steam Sterilization
[00811714035338]
Moist Heat or Steam Sterilization
[00811714035338]
Moist Heat or Steam Sterilization
[00811714035338]
Moist Heat or Steam Sterilization
[00811714035338]
Moist Heat or Steam Sterilization
[00811714035338]
Moist Heat or Steam Sterilization
[00811714035338]
Moist Heat or Steam Sterilization
[00811714035338]
Moist Heat or Steam Sterilization
[00811714035338]
Moist Heat or Steam Sterilization
[00811714035338]
Moist Heat or Steam Sterilization
[00811714035338]
Moist Heat or Steam Sterilization
[00811714035338]
Moist Heat or Steam Sterilization
[00811714035338]
Moist Heat or Steam Sterilization
[00811714035338]
Moist Heat or Steam Sterilization
[00811714035338]
Moist Heat or Steam Sterilization
[00811714035338]
Moist Heat or Steam Sterilization
[00811714035338]
Moist Heat or Steam Sterilization
[00811714035338]
Moist Heat or Steam Sterilization
[00811714035338]
Moist Heat or Steam Sterilization
[00811714035338]
Moist Heat or Steam Sterilization
[00811714035338]
Moist Heat or Steam Sterilization
[00811714035338]
Moist Heat or Steam Sterilization
[00811714035338]
Moist Heat or Steam Sterilization
[00811714035338]
Moist Heat or Steam Sterilization
[00811714035338]
Moist Heat or Steam Sterilization
[00811714035338]
Moist Heat or Steam Sterilization
[00811714035338]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-03-24 |
| Device Publish Date | 2022-03-16 |
| 00811714035055 | Thunderbolt Screw Driver |
| 00811714035048 | Thunderbolt Drill Guide |
| 00811714035017 | Thunderbolt Tensioner Upper Assembly |
| 00811714035000 | Thunderbolt Tensioner Middle |
| 00811714034997 | Thunderbolt Tensioner Lower |
| 00811714034966 | Thunderbolt Guide Wire Long |
| 00811714034942 | Thunderbolt Drill Guide Insert |
| 00811714034928 | Thunderbolt Button Drill |
| 00811714034911 | Thunderbolt Button Drill Cannulated |
| 00811714035338 | Thunderbolt Instrument Set |
| 00811714035659 | Thunderbolt Button Drill |
| 00811714035956 | Thunderbolt Tensioner Lower - Packaged |
| 00811714036090 | Thunderbolt Button Drill Cannulated |
| 00811714036083 | Thunderbolt Guide Wire Long |
| 00811714036618 | Thunderbolt Drill Guide Insert |
| 00811714036601 | Thunderbolt Guide Wire (K Wire) |
| 00811714036595 | Thunderbolt Tensioner Top |
| 00811714036588 | Thunderbolt Tensioner Middle |
| 00811714036571 | Thunderbolt Tensioner Lower |
| 00811714036564 | Thunderbolt Reusable Screwdriver |
| 00811714036557 | Thunderbolt Button Drill - Cannulated |
| 00811714036540 | Thunderbolt Button Drill |
| 00811714036533 | Thunderbolt Drill Guide |
| 00811714036496 | Thunderbolt Instrument Set |
| 00811714036465 | Thunder Bolt Two-Holed Plate |
| 00811714036458 | Thunderbolt Implant |