| Primary Device ID | 00850000065000 |
| NIH Device Record Key | aa6beb00-2c5b-4c68-93fe-1f4e28b52168 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FilmQA Pro |
| Version Model Number | 7.0 |
| Company DUNS | 152728887 |
| Company Name | ASHLAND SPECIALTY INGREDIENTS G.P. |
| 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850000065000 [Primary] |
| MWW | Accessory - Film Dosimetry System |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-10-01 |
| Device Publish Date | 2021-09-23 |
| 00850000065000 | 7.0 |
| 00810106410845 | Radiation/Radiology Software |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() FILMQA PRO 97076639 not registered Live/Pending |
ISP Investments LLC 2021-10-15 |