Primary Device ID | 00811714034928 |
NIH Device Record Key | ae6d3832-48f1-4f82-8b2c-9ee4da484072 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Thunderbolt |
Version Model Number | 909001-0000 |
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 | 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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00811714034928 [Primary] |
LXH | Orthopedic Manual Surgical Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00811714034928]
Moist Heat or Steam Sterilization
[00811714034928]
Moist Heat or Steam Sterilization
[00811714034928]
Moist Heat or Steam Sterilization
[00811714034928]
Moist Heat or Steam Sterilization
[00811714034928]
Moist Heat or Steam Sterilization
[00811714034928]
Moist Heat or Steam Sterilization
[00811714034928]
Moist Heat or Steam Sterilization
[00811714034928]
Moist Heat or Steam Sterilization
[00811714034928]
Moist Heat or Steam Sterilization
[00811714034928]
Moist Heat or Steam Sterilization
[00811714034928]
Moist Heat or Steam Sterilization
[00811714034928]
Moist Heat or Steam Sterilization
[00811714034928]
Moist Heat or Steam Sterilization
[00811714034928]
Moist Heat or Steam Sterilization
[00811714034928]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-03-23 |
Device Publish Date | 2022-03-15 |
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 |