Primary Device ID | 00850020142330 |
NIH Device Record Key | 0e9b36ad-b371-4891-a970-7158e8610df9 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Essential Thera-P |
Version Model Number | EPT9028 |
Company DUNS | 826316098 |
Company Name | PIVOTAL HEALTH SOLUTIONS, INC. |
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 | false |
Serial Number | true |
Manufacturing Date | true |
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 |