| Primary Device ID | 00850040295047 |
| NIH Device Record Key | ebc48eb7-9c0b-45dd-8b02-0f23245edb3c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | M&S Technologies Smart System® 20/20 |
| Version Model Number | Smart System 20/20 |
| 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 | 00850040295023 [Package] Contains: 00850040295566 Package: SS-2020-A [1 Units] In Commercial Distribution |
| GS1 | 00850040295030 [Package] Contains: 00850040295566 Package: SS2020-AT [1 Units] In Commercial Distribution |
| GS1 | 00850040295047 [Package] Contains: 00850040295566 Package: SS-2020-USA [1 Units] In Commercial Distribution |
| GS1 | 00850040295054 [Package] Contains: 00850040295566 Package: SS-2020-USAi [1 Units] In Commercial Distribution |
| GS1 | 00850040295092 [Package] Contains: 00850040295566 Package: ATS-Upgrade-T [1 Units] In Commercial Distribution |
| GS1 | 00850040295221 [Package] Contains: 00850040295566 Package: SS2020-AT-USA [1 Units] In Commercial Distribution |
| GS1 | 00850040295245 [Package] Contains: 00850040295566 Package: SS-2020-Ai [1 Units] In Commercial Distribution |
| GS1 | 00850040295269 [Package] Contains: 00850040295566 Package: SS-2020-USA-MH [1 Units] In Commercial Distribution |
| GS1 | 00850040295337 [Package] Contains: 00850040295566 Package: APP-Customlink [1 Units] In Commercial Distribution |
| GS1 | 00850040295344 [Package] Contains: 00850040295566 Package: ATS-Upgrade [1 Units] In Commercial Distribution |
| GS1 | 00850040295368 [Package] Contains: 00850040295566 Package: SS-2020-MAC-SFT [1 Units] In Commercial Distribution |
| GS1 | 00850040295375 [Package] Contains: 00850040295566 Package: SS-2020-MAC-SFTi [1 Units] In Commercial Distribution |
| GS1 | 00850040295382 [Package] Contains: 00850040295566 Package: SS-2020-PC-SFT [1 Units] In Commercial Distribution |
| GS1 | 00850040295399 [Package] Contains: 00850040295566 Package: SS-2020-PC-SFTi [1 Units] In Commercial Distribution |
| GS1 | 00850040295405 [Package] Contains: 00850040295566 Package: SS-2020-SFT [1 Units] In Commercial Distribution |
| GS1 | 00850040295412 [Package] Contains: 00850040295566 Package: SS-2020-Upgrade [1 Units] In Commercial Distribution |
| GS1 | 00850040295504 [Package] Contains: 00850040295566 Package: SS-Upgrade-MH [1 Units] In Commercial Distribution |
| GS1 | 00850040295511 [Package] Contains: 00850040295566 Package: STD to 2020 Upgrade [1 Units] In Commercial Distribution |
| GS1 | 00850040295535 [Package] Contains: 00850040295566 Package: TMS-SS-2020 [1 Units] In Commercial Distribution |
| GS1 | 00850040295566 [Primary] |
| GS1 | 00850040295610 [Package] Contains: 00850040295566 Package: M-SS-2020T2 [1 Units] In Commercial Distribution |
| GS1 | 00850040295627 [Package] Contains: 00850040295566 Package: M-SS-2020T2 (USA) [1 Units] In Commercial Distribution |
| GS1 | 00850040295634 [Package] Contains: 00850040295566 Package: R-AIO-USA-UPG [1 Units] In Commercial Distribution |
| GS1 | 00850040295658 [Package] Contains: 00850040295566 Package: R-CPU-UPG [1 Units] In Commercial Distribution |
| GS1 | 00850040295672 [Package] Contains: 00850040295566 Package: R-AIO-20-UPG [1 Units] In Commercial Distribution |
| GS1 | 00850040295696 [Package] Contains: 00850040295566 Package: R-AIO-USA-MH [1 Units] In Commercial Distribution |
| GS1 | 00850040295702 [Package] Contains: 00850040295566 Package: SS2020-AW [1 Units] In Commercial Distribution |
| GS1 | 00850040295719 [Package] Contains: 00850040295566 Package: SS2020-AW-USA [1 Units] In Commercial Distribution |
| GS1 | 00850040295788 [Package] Contains: 00850040295566 Package: SS-2020-P [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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| 00850040295139 - M&S Technologies Clinical Trial Suite® | 2022-07-14 M&S Technologies Clinical Trial Suite® |
| 00850040295214 - M&S Technologies Melbourne Rapid Fields Device In-Clinic | 2022-07-14 M&S Technologies Melbourne Rapid Fields Device In-Clinic |
| 00850040295351 - M&S Technologies ACUITYex | 2022-07-14 M&S Technologies ACUITYex |
| 00850040295559 - M&S Technologies Smart System® Standard | 2022-07-14 M&S Technologies Smart System® Standard |
| 00850040295047 - M&S Technologies Smart System® 20/20 | 2022-07-14M&S Technologies Smart System® 20/20 |
| 00850040295047 - M&S Technologies Smart System® 20/20 | 2022-07-14 M&S Technologies Smart System® 20/20 |