ULINE Surgical Mask with Eye Shield S-21078

GUDID 10851253007424

Light blue polypropylene surgical Mask with ear loops and eye shield with adjustable aluminum nose piece.

ULINE, INC.

Surgical/medical face mask, single-use
Primary Device ID10851253007424
NIH Device Record Keybd10da60-a8c8-4fee-9f74-08678e39f01e
Commercial Distribution StatusIn Commercial Distribution
Brand NameULINE Surgical Mask with Eye Shield
Version Model NumberS-21078
Catalog NumberS-21078
Company DUNS039612668
Company NameULINE, INC.
Device Count25
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 Datetrue
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
GS100851253007427 [Unit of Use]
GS110851253007424 [Primary]
GS130851253007428 [Package]
Package: Carton [8 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 Date2017-01-24

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