Makrite Industries Inc.

GUDID 06924997807876

NIOSH approved and FDA cleared cone style N95 disposable respirator, medium and large size.

DONGGUAN SURE_ON PLASTIC & FIBER PRODUCTS CO.,LTD.

Surgical/medical respirator, non-antimicrobial, single-use
Primary Device ID06924997807876
NIH Device Record Key6fdd6831-b872-4d45-bc22-b99598ed4fd0
Commercial Distribution StatusIn Commercial Distribution
Brand NameMakrite Industries Inc.
Version Model Number9500-N95
Company DUNS528182541
Company NameDONGGUAN SURE_ON PLASTIC & FIBER PRODUCTS CO.,LTD.
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 Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106924997807876 [Primary]

FDA Product Code

MSHRespirator, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-06
Device Publish Date2023-09-28

On-Brand Devices [Makrite Industries Inc.]

06924997819114NIOSH approved and FDA cleared cone style N95 disposable respirator, adult small size.
06924997809061NIOSH approved and FDA cleared duckbill style N95 disposable respirator, regular size.
06924997807876NIOSH approved and FDA cleared cone style N95 disposable respirator, medium and large size.

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