Sure & Me

GUDID 26973069130019

Jiangmen Sure&Me Medical Product Co., Ltd.

Surgical/medical face mask, single-use
Primary Device ID26973069130019
NIH Device Record Keybfd9d3d6-748d-41d7-9a8b-4b211ac66f45
Commercial Distribution StatusIn Commercial Distribution
Brand NameSure & Me
Version Model NumberMP002-6
Company DUNS544326854
Company NameJiangmen Sure&Me Medical Product Co., Ltd.
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 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
GS106973069130015 [Unit of Use]
GS116973069130012 [Primary]
GS126973069130019 [Package]
Contains: 16973069130012
Package: [40 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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-09
Device Publish Date2021-03-01

On-Brand Devices [Sure & Me]

26973069130019MP002-6
26973069130002MP002-5

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