| Primary Device ID | 20810050855697 |
| NIH Device Record Key | 29440ca4-cbdf-477e-8c75-e326188ce200 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Microscope Sldies |
| Version Model Number | LC0101 |
| Company DUNS | 600850213 |
| Company Name | TYPENEX MEDICAL LLC |
| Device Count | 72 |
| 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 | 00810050855693 [Unit of Use] |
| GS1 | 10810050855690 [Primary] |
| GS1 | 20810050855697 [Package] Contains: 10810050855690 Package: Case [20 Units] In Commercial Distribution |
| KEW | Slides, Microscope |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-02-11 |
| Device Publish Date | 2025-02-03 |
| 10810050855782 - Fibernex Laser System | 2025-08-05 Fibernex Go Laser System |
| 20810050855772 - Microscope Slides | 2025-07-22 Liquid Based Cytology Slides, Uncoated, Single Circle, Ground Edge, 45° Corners, Blue (LC0104B) |
| 20810050855765 - Microscope Slides | 2025-07-16 Premium Microscope Slide, Ground Edges, 45° Corners, White (PS0204W) |
| 20810050855741 - Microscope Slides | 2025-06-25 Premium Microscope Slide, Positive Charged, Thermal Printing, Ground Edges, 45° Corners - White Frosted (PS0404WXT) |
| 20810050855758 - Microscope Slides | 2025-06-25 Premium Microscope Slide, Positive Charged, Thermal Printing, Ground Edges, 45° Corners - Yellow Frosted (PS0404YXT) |
| 00810050855457 - Rad Control | 2025-06-02 15 Gy Universal Irradiation Tag |
| 00810050855471 - Rad Control | 2025-06-02 25 Gy Universal Irradiation Tag |
| 20810050855697 - Microscope Sldies | 2025-02-11Liquid Based Cytology Slides, Single Printed Circle, Ground Edge 45° Corners |
| 20810050855697 - Microscope Sldies | 2025-02-11 Liquid Based Cytology Slides, Single Printed Circle, Ground Edge 45° Corners |