4PLY SURGICAL MASK

GUDID 08809783490532

UNICO GLOBAL INC

Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use
Primary Device ID08809783490532
NIH Device Record Keyedaf8aaf-0725-460d-8c49-ef47b6ebb0cc
Commercial Distribution StatusIn Commercial Distribution
Brand Name4PLY SURGICAL MASK
Version Model NumberFM-EU2002
Company DUNS690513726
Company NameUNICO GLOBAL INC
Device Count50
DM Exemptfalse
Pre-market Exempttrue
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 Perscriptiontrue
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS108809783490532 [Unit of Use]
GS108809783490631 [Primary]

FDA Product Code

QKRFace Mask Per Enforcement Policy For Face Masks And Respirators During The Declared Public Health Emergency

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-28
Device Publish Date2022-03-18

Devices Manufactured by UNICO GLOBAL INC

08809783490105 - Unico Global Level 3 Surgical Gown (Film-Reinforced SMS)2022-03-28
08809783490112 - Unico Global Level 3 Surgical Gown (Film-Reinforced SMS)2022-03-28
08809783490129 - Unico Global Level 3 Surgical Gown (Film-Reinforced SMS)2022-03-28
08809783490136 - Unico Global Level 3 Surgical Gown (Film-Reinforced SMS)2022-03-28
08809783490143 - Unico Global Level 3 Surgical Gown (Film-Reinforced SMS)2022-03-28
08809783490150 - Unico Global Level 3 Surgical Gown (Film-Reinforced SMS)2022-03-28
08809783490167 - Unico Global Level 3 Surgical Gown (Film-Reinforced SMS)2022-03-28
08809783490174 - Unico Global Level 3 Surgical Gown (Film-Reinforced SMS)2022-03-28

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