| Primary Device ID | 00811714032603 |
| NIH Device Record Key | e75d80a1-543b-4067-b933-c5a424769e57 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Spirit PEEK |
| Version Model Number | 900001-1000 |
| 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 | 00811714032603 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00811714032603]
Moist Heat or Steam Sterilization
[00811714032603]
Moist Heat or Steam Sterilization
[00811714032603]
Moist Heat or Steam Sterilization
[00811714032603]
Moist Heat or Steam Sterilization
[00811714032603]
Moist Heat or Steam Sterilization
[00811714032603]
Moist Heat or Steam Sterilization
[00811714032603]
Moist Heat or Steam Sterilization
[00811714032603]
Moist Heat or Steam Sterilization
[00811714032603]
Moist Heat or Steam Sterilization
[00811714032603]
Moist Heat or Steam Sterilization
[00811714032603]
Moist Heat or Steam Sterilization
[00811714032603]
Moist Heat or Steam Sterilization
[00811714032603]
Moist Heat or Steam Sterilization
[00811714032603]
Moist Heat or Steam Sterilization
[00811714032603]
Moist Heat or Steam Sterilization
[00811714032603]
Moist Heat or Steam Sterilization
[00811714032603]
Moist Heat or Steam Sterilization
[00811714032603]
Moist Heat or Steam Sterilization
[00811714032603]
Moist Heat or Steam Sterilization
[00811714032603]
Moist Heat or Steam Sterilization
[00811714032603]
Moist Heat or Steam Sterilization
[00811714032603]
Moist Heat or Steam Sterilization
[00811714032603]
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 |
| 00811714035383 | Spirit PEEK Guide Wire Standard |
| 00811714034638 | Spirit PEEK Screwdriver |
| 00811714032627 | Spirit PEEK Tap 12mm |
| 00811714032610 | Spirit PEEK Tap 11mm |
| 00811714032603 | Spirit PEEK Tap 10mm |
| 00811714032597 | Spirit PEEK Tap 9mm |
| 00811714032580 | Spirit PEEK Tap 8mm |
| 00811714032573 | Spirit PEEK Tap 7mm |
| 00811714032658 | Spirit PEEK Instrument Set |