| Primary Device ID | D832MK115 |
| NIH Device Record Key | b9fc8c3c-fa9c-4a1d-89b1-add6a6c01c60 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Plasdent Fluid Proof Earloop Mask |
| Version Model Number | MK1 |
| Catalog Number | MK1-1 |
| Company DUNS | 190377184 |
| Company Name | PLASDENT CORPORATION |
| Device Count | 1 |
| 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D832MK11 [Primary] |
| HIBCC | D832MK111 [Package] Contains: D832MK11 Package: BOX [50 Units] In Commercial Distribution |
| HIBCC | D832MK112 [Package] Contains: D832MK111 Package: Case [20 Units] In Commercial Distribution |
| HIBCC | D832MK115 [Package] Contains: D832MK11 Package: CASE [1000 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 | 2 |
| Public Version Date | 2020-05-06 |
| Device Publish Date | 2018-09-21 |
| D832MK165 | FLUIDPROOF (TM) Earloop Mask - Pink (50pcs/box) |
| D832MK145 | FLUIDPROOF (TM) Earloop Mask - Green (50pcs/box) |
| D832MK135 | FLUIDPROOF (TM) Earloop Mask - Yellow (50pcs/box) |
| D832MK125 | FLUIDPROOF (TM) Earloop Mask - Blue (50pcs/box) |
| D832MK1101 | FLUIDPROOF (TM) Earloop Mask - Lavender (50pcs/box) |
| D832MK115 | FLUIDPROOF (TM) Earloop Mask - White (50pcs/box) |