Primary Device ID | M9432001570000 |
NIH Device Record Key | a4b2fae3-7ec9-4c2f-8704-421f48c7412a |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | 20-0157-000 |
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 | M9432001570000 [Primary] |
LXH | Orthopedic Manual Surgical Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[M9432001570000]
Moist Heat or Steam Sterilization
[M9432001570000]
Moist Heat or Steam Sterilization
[M9432001570000]
Moist Heat or Steam Sterilization
[M9432001570000]
Moist Heat or Steam Sterilization
[M9432001570000]
Moist Heat or Steam Sterilization
[M9432001570000]
Moist Heat or Steam Sterilization
[M9432001570000]
Moist Heat or Steam Sterilization
[M9432001570000]
Moist Heat or Steam Sterilization
[M9432001570000]
Moist Heat or Steam Sterilization
[M9432001570000]
Moist Heat or Steam Sterilization
[M9432001570000]
Moist Heat or Steam Sterilization
[M9432001570000]
Moist Heat or Steam Sterilization
[M9432001570000]
Moist Heat or Steam Sterilization
[M9432001570000]
Moist Heat or Steam Sterilization
[M9432001570000]
Moist Heat or Steam Sterilization
[M9432001570000]
Moist Heat or Steam Sterilization
[M9432001570000]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-07-11 |
Device Publish Date | 2024-07-03 |
M9432000010010 - Minuteman | 2024-07-11 Flexible Guidewire |
M9432001570000 - NA | 2024-07-11Long Nose with Slap Hammer |
M9432001570000 - NA | 2024-07-11 Long Nose with Slap Hammer |
M9432001580000 - Minuteman | 2024-07-11 Surgical Probe |
M9432001620040 - Liberty SI | 2024-07-02 Short Guidewire, Trocar |
M9432001620050 - Liberty SI | 2024-07-02 Short Guidewire, Trocar Sharp |
M9432001630010 - Liberty SI | 2024-07-02 Guidewire Extension (470mm) |
M9432001680010 - Liberty SI | 2024-07-02 Drill (9.4mm) Jacobs Connection |
M9432001690000 - Liberty SI | 2024-07-02 Drill (10.8mm) |