Primary Device ID | M52510330000 |
NIH Device Record Key | ffe76e28-f5a2-4a35-8116-19eed9381aef |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Neutral Density Densitometer Control for SPIFE 4000 |
Version Model Number | 1033000 |
Company DUNS | 836287433 |
Company Name | HELENA LABORATORIES CORPORATION |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
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 | 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 |