| Primary Device ID | 20814707022753 |
| NIH Device Record Key | 238067e1-fc0d-471d-b1f7-a06152e599fe |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Precept ® |
| Version Model Number | 15112 |
| Company DUNS | 783912892 |
| Company Name | PRECEPT MEDICAL PRODUCTS, INC. |
| Device Count | 50 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | 800-438-5827 |
| customerservice@preceptmed.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00814707022759 [Unit of Use] |
| GS1 | 10814707022756 [Primary] |
| GS1 | 20814707022753 [Package] Contains: 10814707022756 Package: [10 Units] In Commercial Distribution |
| FXX | Mask, Surgical |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-05-06 |
| Device Publish Date | 2018-01-31 |
| 20814707022753 | Procedure Mask |
| 20814707022692 | Lite & Cool Surgical Mask with Anti-Glare Shield |
| 20814707022685 | FluidGard® 160 Anti-Fog Procedure Mask |
| 20814707022661 | FluidGard® 160 Anti-Fog Surgical Mask |
| 10814707021254 | Fluidgard® 160 Anti-Fog Surgical Mask with Anti-Glare Shield |
| 20814707021244 | FluidGard® 160 Anti-Fog Procedure Mask with Anti-Glare Shield |
| 20814707020001 | FLUIDGARD ® 160 ANTI-FOG PROCEDURE MASK WITH EXTENDED SHIELD |