Primary Device ID | D832MK125 |
NIH Device Record Key | 6226b054-0279-43c2-9c4d-462e84d7e3f8 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Plasdent Fluid Proof Earloop Mask |
Version Model Number | MK1 |
Catalog Number | MK1-2 |
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 | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D832MK12 [Primary] |
HIBCC | D832MK121 [Package] Contains: D832MK12 Package: box [50 Units] In Commercial Distribution |
HIBCC | D832MK122 [Package] Contains: D832MK121 Package: Case [20 Units] In Commercial Distribution |
HIBCC | D832MK125 [Package] Contains: D832MK12 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) |