| Primary Device ID | 10848340001960 |
| NIH Device Record Key | 53c87e6b-ec1e-4689-89fa-07769735c2ca |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | UNBRANDED |
| Version Model Number | 07-KC02 |
| Company DUNS | 130785884 |
| Company Name | ADVANCE MEDICAL DESIGNS, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00848340001963 [Primary] |
| GS1 | 10848340001960 [Package] Contains: 00848340001963 Package: [25 Units] In Commercial Distribution |
| HRM | MICROSCOPE, OPERATING & ACCESSORIES, AC-POWERED, OPHTHALMIC |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10848340001960]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-05-22 |
| Device Publish Date | 2020-05-14 |