| 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 |
| B90829211908 - Main-AXS Needle-Retropsoas | 2025-05-08 Single-Use, Bone Access Needle, Sterile Trocar Stylus & Blunt Cannula with cm Depth Marks |
| 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 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MAIN-KNIFE 88806161 not registered Live/Pending |
Mainstream Medical Devices, LLC 2020-02-21 |