| Primary Device ID | 00810050851985 | 
| NIH Device Record Key | fa0c72b3-7d55-4080-b1a3-ddbb5c60fe67 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Medical Face Shield | 
| Version Model Number | FS0101 | 
| Company DUNS | 600850213 | 
| Company Name | TYPENEX MEDICAL LLC | 
| Device Count | 200 | 
| 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 | false | 
| Serial Number | false | 
| Manufacturing Date | false | 
| Expiration Date | false | 
| 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 | 00810050851978 [Unit of Use] | 
| GS1 | 00810050851985 [Primary] | 
| LYU | Accessory, Surgical Apparel | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2022-12-06 | 
| Device Publish Date | 2022-11-28 | 
| 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 | 2025-02-11 Liquid Based Cytology Slides, Single Printed Circle, Ground Edge 45° Corners |