Primary Device ID | B90845105193 |
NIH Device Record Key | f5a3fb7d-802d-416e-b1eb-e31c270bb36e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Main-Knife |
Version Model Number | 451-05-193 |
Company DUNS | 071513432 |
Company Name | Mainstream Medical Devices, 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 | true |
Lot Batch | false |
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 | B90845105193 [Primary] |
EMF | Knife, Surgical |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-07-10 |
Device Publish Date | 2023-06-30 |
B90830825080 - Main-Mallet | 2025-04-14 Single-Use, Mallet, 8" Small Contoured Handle, 8oz Head Weight, Sterile |
B90831225080 - Main-Mallet | 2025-04-14 Single-Use, Mallet, 8" Small Contoured Handle, 12oz Head Weight, Sterile |
B90831625080 - Main-Mallet | 2025-04-14 Single-Use, Mallet, 8" Small Contoured Handle, 16oz Head Weight, Sterile |
B90831635080 - Main-Mallet | 2025-04-14 Single-Use, Mallet, 8" Slotted, Small Contoured Handle, 16oz Head Weight, Sterile |
B908350011000 - Main-Mallet-Spinal Simplicity | 2025-04-14 Single-Use, Surgical Mallet, Slotted, 8" Small Contoured Handle, 16oz Head Weight, Spinal Simplicity, Sterile |
B908350008000 - Main-AXS Needle-Spinal Simplicity | 2024-12-11 Single Use, Bone Access Needle, Sterile Blunt Stylus & Blunt Cannula with Extra Trocar Stylus |
B908350009000 - Main-AXS Needle-Spinal Simplicity | 2024-12-11 Single-Use, Bone Access Needle, Sterile Trocar Stylus & Blunt Cannula |
B90831020150 - Sterile Drill Bit | 2024-08-19 Single-Use, Non-cannulated Drill, Sterile |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() MAIN-KNIFE 88806161 not registered Live/Pending |
Mainstream Medical Devices, LLC 2020-02-21 |