myONE S55

GUDID 80726893510179

12 Lubricated Male latex Condoms

GLOBAL PROTECTION CORP.

Basic male condom, Hevea-latex
Primary Device ID80726893510179
NIH Device Record Key23583be6-2cc2-4fad-8636-fc83e1b6df22
Commercial Distribution StatusIn Commercial Distribution
Brand NamemyONE S55
Version Model NumberMYONE-S55-12
Company DUNS364614362
Company NameGLOBAL PROTECTION CORP.
Device Count12
DM Exempttrue
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100726893510173 [Primary]
GS100726893510869 [Primary]
GS180726893510179 [Unit of Use]

FDA Product Code

HISCondom

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-11
Device Publish Date2020-06-03

Devices Manufactured by GLOBAL PROTECTION CORP.

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