| 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 |
| Phone | +1(800)231-5663 |
| helena@helena.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M52510330000 [Primary] |
| CEF | ELECTROPHORETIC, PROTEIN FRACTIONATION |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2022-10-10 |
| Device Publish Date | 2017-03-17 |
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