Plasdent Fluid Proof Earloop Mask MK1-10L

GUDID D832MK1101

FLUIDPROOF (TM) Earloop Mask - Lavender (50pcs/box)

PLASDENT CORPORATION

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Primary Device IDD832MK1101
NIH Device Record Key42a42b7a-a7ee-4bd0-a69c-7c0df5d59c64
Commercial Distribution StatusIn Commercial Distribution
Brand NamePlasdent Fluid Proof Earloop Mask
Version Model NumberMK1
Catalog NumberMK1-10L
Company DUNS190377184
Company NamePLASDENT CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD832MK110 [Primary]
HIBCCD832MK1101 [Package]
Contains: D832MK110
Package: BOX [50 Units]
In Commercial Distribution
HIBCCD832MK1102 [Package]
Package: Case [20 Units]
In Commercial Distribution
HIBCCD832MK1105 [Package]
Contains: D832MK110
Package: CASE [1000 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FXXMask, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-05-06
Device Publish Date2018-09-21

On-Brand Devices [Plasdent Fluid Proof Earloop Mask ]

D832MK165FLUIDPROOF (TM) Earloop Mask - Pink (50pcs/box)
D832MK145FLUIDPROOF (TM) Earloop Mask - Green (50pcs/box)
D832MK135FLUIDPROOF (TM) Earloop Mask - Yellow (50pcs/box)
D832MK125FLUIDPROOF (TM) Earloop Mask - Blue (50pcs/box)
D832MK1101FLUIDPROOF (TM) Earloop Mask - Lavender (50pcs/box)
D832MK115FLUIDPROOF (TM) Earloop Mask - White (50pcs/box)

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