Procedure Face Mask with Ear Loop and Plastic Shield

GUDID 00616784220239

DYNAREX CORPORATION

Surgical/medical face mask, single-use
Primary Device ID00616784220239
NIH Device Record Keybd957130-3de6-4f7f-ab87-fba076f01ac7
Commercial Distribution StatusIn Commercial Distribution
Brand NameProcedure Face Mask with Ear Loop and Plastic Shield
Version Model Number2202
Company DUNS008124539
Company NameDYNAREX CORPORATION
Device Count50
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
GS100616784220215 [Unit of Use]
GS100616784220222 [Primary]
GS100616784220239 [Package]
Contains: 00616784220222
Package: [4 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 Number4
Public Version Date2020-05-06
Device Publish Date2016-09-24

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