Primary Device ID | M9432001990000 |
NIH Device Record Key | da27ed98-4065-4d5c-83aa-d4c9f90b2a07 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Patriot SI |
Version Model Number | 20-0199-000 |
Company DUNS | 963359513 |
Company Name | Spinal Simplicity, 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 |
---|---|
HIBCC | M9432001990000 [Primary] |
LXH | Orthopedic Manual Surgical Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[M9432001990000]
Moist Heat or Steam Sterilization
[M9432001990000]
Moist Heat or Steam Sterilization
[M9432001990000]
Moist Heat or Steam Sterilization
[M9432001990000]
Moist Heat or Steam Sterilization
[M9432001990000]
Moist Heat or Steam Sterilization
[M9432001990000]
Moist Heat or Steam Sterilization
[M9432001990000]
Moist Heat or Steam Sterilization
[M9432001990000]
Moist Heat or Steam Sterilization
[M9432001990000]
Moist Heat or Steam Sterilization
[M9432001990000]
Moist Heat or Steam Sterilization
[M9432001990000]
Moist Heat or Steam Sterilization
[M9432001990000]
Moist Heat or Steam Sterilization
[M9432001990000]
Moist Heat or Steam Sterilization
[M9432001990000]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-11-08 |
Device Publish Date | 2024-10-31 |
M9432001940000 | Guidewire, Blunt |
M9432001910000 | Impactor |
M9432001900000 | Drillcorticator |
M9432001890000 | Joint Sleeve |
M9432001880000 | Joint Finder |
M9432001860000 | Guidewire, Blunt |
M9432001850000 | Insertion Instrument |
M9430018700000 | Guidewire, Trocar |
M9431001750000 | Posterior SI Joint Fusion Implant |
M9432001990000 | Luer Insertion Instrument |