| Primary Device ID | 00850040295559 |
| NIH Device Record Key | c3652316-e327-456c-9a07-3f870764f5cd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | M&S Technologies Smart System® Standard |
| Version Model Number | Smart System Standard |
| Company DUNS | 118021111 |
| Company Name | The Hilsinger Company Parent LLC |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850040295085 [Package] Package: SS-STD [1 Units] In Commercial Distribution |
| GS1 | 00850040295467 [Package] Package: SS-STD-PC-SFT [1 Units] In Commercial Distribution |
| GS1 | 00850040295481 [Package] Package: SS-STD-MAC-SFT [1 Units] In Commercial Distribution |
| GS1 | 00850040295498 [Package] Package: SS-STD-PC-SFTi [1 Units] In Commercial Distribution |
| GS1 | 00850040295559 [Primary] |
| GS1 | 00850040295689 [Package] Package: R-AIO-STD-UPG [1 Units] In Commercial Distribution |
| HOS | Projector, Ophthalmic |
| QTO | Digital Visual Acuity Test |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-07-14 |
| Device Publish Date | 2022-07-06 |
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| 00850040295351 - M&S Technologies ACUITYex | 2022-07-14 M&S Technologies ACUITYex |
| 00850040295559 - M&S Technologies Smart System® Standard | 2022-07-14M&S Technologies Smart System® Standard |
| 00850040295559 - M&S Technologies Smart System® Standard | 2022-07-14 M&S Technologies Smart System® Standard |
| 00850040295047 - M&S Technologies Smart System® 20/20 | 2022-07-14 M&S Technologies Smart System® 20/20 |