| Primary Device ID | 00836230004002 |
| NIH Device Record Key | 494d0111-0626-4c5b-b841-23224cf5675f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Image Cover 36R |
| Version Model Number | 5002 |
| 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 | 00836230004002 [Primary] |
| GS1 | 01836230004001 [Package] Package: [15 Units] In Commercial Distribution |
| GS1 | 02836230004000 [Package] Contains: 01836230004001 Package: [4 Units] In Commercial Distribution |
| KQM | Camera, Surgical And Accessories |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-11-23 |
| Device Publish Date | 2022-11-15 |
| 00836230004392 - Microscope Cover MITAKA 137/380 HLT | 2025-06-24 Medical equipment drape, single-use |
| 00836230004408 - Microscope Cover MITAKA mm80, mm90, 80/276 | 2025-06-24 Medical equipment drape, single-use |
| 07290115960594 - Microscope Cover MITAKA mm80, mm90, 80/266 | 2025-06-19 Medical equipment drape, single-use |
| 01836230000737 - MS DRAPE For Zeiss W/HLT ANGLE LENS 45”x118”, 115x300cm | 2022-11-28 Medical equipment drape, single-use |
| 01836230000744 - Microscope Cover ZEISS 137/380 6.50 HLT | 2022-11-28 Medical equipment drape, single-use |
| 01836230000768 - Microscope Cover ZEISS "MD" 115/260 6.50 | 2022-11-28 Medical equipment drape, single-use |
| 01836230002007 - C-Arm Cover UNIVERSAL 112/183 | 2022-11-28 Medical equipment drape, single-use |
| 01836230002014 - C-Arm Cover IMAGE INTENSHFIER 115/240 | 2022-11-28 Medical equipment drape, single-use |