| Primary Device ID | 00811714035406 |
| NIH Device Record Key | b9ac774e-05b0-4edd-8567-279e8eb6591f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lightning |
| Version Model Number | 905001-0002-P02 |
| Catalog Number | 905001-0002-P02 |
| 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 | 00811714035406 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00811714035406]
Moist Heat or Steam Sterilization
[00811714035406]
Moist Heat or Steam Sterilization
[00811714035406]
Moist Heat or Steam Sterilization
[00811714035406]
Moist Heat or Steam Sterilization
[00811714035406]
Moist Heat or Steam Sterilization
[00811714035406]
Moist Heat or Steam Sterilization
[00811714035406]
Moist Heat or Steam Sterilization
[00811714035406]
Moist Heat or Steam Sterilization
[00811714035406]
Moist Heat or Steam Sterilization
[00811714035406]
Moist Heat or Steam Sterilization
[00811714035406]
Moist Heat or Steam Sterilization
[00811714035406]
Moist Heat or Steam Sterilization
[00811714035406]
Moist Heat or Steam Sterilization
[00811714035406]
Moist Heat or Steam Sterilization
[00811714035406]
Moist Heat or Steam Sterilization
[00811714035406]
Moist Heat or Steam Sterilization
[00811714035406]
Moist Heat or Steam Sterilization
[00811714035406]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-24 |
| Device Publish Date | 2023-10-16 |
| 00811714030258 | Lightning Probe Long |
| 00811714030241 | Lightning Probe Short |
| 00811714030210 | Lightning Guide Tube V-Mouth Short |
| 00811714030203 | Lightning Guide Tube Crown Short |
| 00811714030173 | Lightning Guide Tube V-Mouth Long |
| 00811714030166 | Lightning Guide Tube Crown Long |
| 00811714030142 | Lightning Drill Short |
| 00811714030128 | Lightning Drill Long |
| 00811714030098 | Lightning Suture Anchor Short |
| 00811714030081 | Lightning Suture Anchor Long |
| 00811714034416 | Lightning Suture Anchor |
| 00811714034409 | Lightning Suture Anchor |
| 00811714034393 | Lightning Suture Anchor |
| 00811714034669 | Lightning Standard Drill Long |
| 00811714034652 | Lightning Standard Drill Medium |
| 00811714034645 | Lightning Standard Drill Short |
| 00811714034614 | Lightning Blunt Probe |
| 00811714034584 | Lightning Trocar Probe Long |
| 00811714034577 | Lightning Trocar Probe Medium |
| 00811714034560 | Lightning Trocar Probe Short |
| 00811714034539 | 905003-0003 |
| 00811714034522 | Lightning Guide Tube V-Mouth Medium |
| 00811714034492 | Lightning Guide Tube Crown Long |
| 00811714034485 | Lightning Guide Tube Crown Medium |
| 00811714034478 | Lightning Guide Tube Crown Short |
| 00811714032702 | Lightning Long Instrument Set |
| 00811714032696 | Lightning Medium Instrument Set |
| 00811714032689 | Lightning Short Instrument Set |
| 00811714035826 | Lightning Long Drill |
| 00811714035512 | Lightning Guide Tube V-Mouth Medium |
| 00811714035505 | Lightning Trocar Probe Medium |
| 00811714035406 | Lightning Standard Drill Medium |
| 00811714035949 | Lightning Trocar Probe Long - Packaged |
| 00811714036120 | Lightning Blunt Probe |