Primary Device ID | B631TCNK2ZL32M1 |
NIH Device Record Key | d8896224-851d-4eb6-a259-8b53b535a243 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Surelead |
Version Model Number | TCNK2ZL32M |
Company DUNS | 078861998 |
Company Name | Authentic Medical |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | MR Unsafe |
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 | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B631TCNK2ZL32M1 [Primary] |
IKD | Cable, Electrode |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-03-20 |
Device Publish Date | 2023-03-10 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SURELEAD 98844045 not registered Live/Pending |
Authentic Options LLC 2024-11-08 |