| Primary Device ID | 07350101640029 |
| NIH Device Record Key | 45bd38bd-8d5a-4f26-a66f-65717f3704e1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sterile Shield |
| Version Model Number | LAF-02 |
| Company DUNS | 427895198 |
| Company Name | Toul Meditech AB |
| Device Count | 50 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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 | 07350101640012 [Unit of Use] |
| GS1 | 07350101640029 [Primary] |
| GS1 | 07350101640036 [Package] Package: Cardbordbox [2 Units] In Commercial Distribution |
| ORC | Air Filter Portable Apparatus |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-11 |
| Device Publish Date | 2019-02-13 |
| 07350101640029 | The Sterile shield LAF 02 is a single-use sterile consumable to be used together with ultra clea |
| 07350101640050 | The Sterile shield LAF 02-D is a single-use sterile consumable to be used together with ultra cl |