Primary Device ID | B390AR10001 |
NIH Device Record Key | 3d89a17f-16ae-42da-99d1-97f223815cc7 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Reprocessed Suture Passer, Transosseous |
Version Model Number | AR-1000 |
Company DUNS | 785616934 |
Company Name | SURETEK MEDICAL |
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 | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |