Primary Device ID | 00811714036021 |
NIH Device Record Key | 716b948e-f03c-468c-be58-9974b913f773 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Stealth |
Version Model Number | 911003-0002-P01 |
Catalog Number | 911003-0002-P01 |
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 | 00811714036021 [Primary] |
LXH | Orthopedic Manual Surgical Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00811714036021]
Moist Heat or Steam Sterilization
[00811714036021]
Moist Heat or Steam Sterilization
[00811714036021]
Moist Heat or Steam Sterilization
[00811714036021]
Moist Heat or Steam Sterilization
[00811714036021]
Moist Heat or Steam Sterilization
[00811714036021]
Moist Heat or Steam Sterilization
[00811714036021]
Moist Heat or Steam Sterilization
[00811714036021]
Moist Heat or Steam Sterilization
[00811714036021]
Moist Heat or Steam Sterilization
[00811714036021]
Moist Heat or Steam Sterilization
[00811714036021]
Moist Heat or Steam Sterilization
[00811714036021]
Moist Heat or Steam Sterilization
[00811714036021]
Moist Heat or Steam Sterilization
[00811714036021]
Moist Heat or Steam Sterilization
[00811714036021]
Moist Heat or Steam Sterilization
[00811714036021]
Moist Heat or Steam Sterilization
[00811714036021]
Moist Heat or Steam Sterilization
[00811714036021]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-04-09 |
Device Publish Date | 2024-04-01 |
00811714035871 | Stealth Instruments |
00811714035741 | Stealth Instrument Tray |
00811714035734 | Stealth Blunt Probe |
00811714035710 | Stealth Probe |
00811714035697 | Stealth Castle Guide Tube |
00811714035673 | Stealth Drill 3.2mm |
00811714035970 | Stealth Soft Bone Drill 3.0mm |
00811714036038 | Stealth Blunt Probe |
00811714036021 | Stealth Probe |
00811714036014 | Stealth Soft Bone Drill 3.0mm |
00811714036007 | Stealth Castle Guide Tube |
00811714035994 | Stealth Drill 3.0mm |