| Primary Device ID | 01836230000508 |
| NIH Device Record Key | 1e30e405-8e62-4a2b-a56c-a48fe15de7a9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Microscope Cover LEICA 137/380 7.00 HLT |
| Version Model Number | 8420H |
| Company DUNS | 532186541 |
| Company Name | PHARMA SEPT MEDICAL PRODUCTS (1995) LTD. |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00836230000509 [Primary] |
| GS1 | 01836230000508 [Package] Contains: 00836230000509 Package: box [5 Units] In Commercial Distribution |
| GS1 | 02836230000507 [Package] Package: box [4 Units] In Commercial Distribution |
| HRM | Microscope, Operating & Accessories, Ac-Powered, Ophthalmic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-11-24 |
| Device Publish Date | 2022-11-16 |
| 01836230000553 | Medical equipment drape, single-use |
| 01836230000508 | Medical equipment drape, single-use |
| 01836230000379 | Medical equipment drape, single-use |