| Primary Device ID | 00811714035758 |
| NIH Device Record Key | c52e2ef7-80eb-432a-9c51-6302ee3109c4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Mini Stealth |
| Version Model Number | 911008-0000 |
| Catalog Number | 911008-0000 |
| 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 | true |
| 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 | 00811714035758 [Primary] |
| FSM | Tray, Surgical, Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00811714035758]
Moist Heat or Steam Sterilization
[00811714035758]
Moist Heat or Steam Sterilization
[00811714035758]
Moist Heat or Steam Sterilization
[00811714035758]
Moist Heat or Steam Sterilization
[00811714035758]
Moist Heat or Steam Sterilization
[00811714035758]
Moist Heat or Steam Sterilization
[00811714035758]
Moist Heat or Steam Sterilization
[00811714035758]
Moist Heat or Steam Sterilization
[00811714035758]
Moist Heat or Steam Sterilization
[00811714035758]
Moist Heat or Steam Sterilization
[00811714035758]
Moist Heat or Steam Sterilization
[00811714035758]
Moist Heat or Steam Sterilization
[00811714035758]
Moist Heat or Steam Sterilization
[00811714035758]
Moist Heat or Steam Sterilization
[00811714035758]
Moist Heat or Steam Sterilization
[00811714035758]
Moist Heat or Steam Sterilization
[00811714035758]
Moist Heat or Steam Sterilization
[00811714035758]
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 |
| 00811714035864 | Mini Stealth Instruments |
| 00811714035758 | Mini Stealth Instrument Tray |
| 00811714035727 | Mini Stealth Blunt Probe |
| 00811714035703 | Mini Stealth Probe |
| 00811714035680 | Mini Stealth Castle Guide Tube |
| 00811714035666 | Mini Stealth Drill 2.1mm |
| 00811714036076 | Mini Stealth Blunt Probe |
| 00811714036069 | Mini Stealth Probe |
| 00811714036052 | Mini Stealth Castle Guide Tube |
| 00811714036045 | Mini Stealth Drill 2.1mm |