myONE S99

GUDID 80726893510216

6 Lubricated Male Latex Condoms

GLOBAL PROTECTION CORP.

Basic male condom, Hevea-latex
Primary Device ID80726893510216
NIH Device Record Keyc05f3816-384b-4b03-8bb8-4756c397471e
Commercial Distribution Discontinuation2022-01-08
Commercial Distribution StatusNot in Commercial Distribution
Brand NamemyONE S99
Version Model NumberMYONE-S99-6
Company DUNS364614362
Company NameGLOBAL PROTECTION CORP.
Device Count6
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
GS100726893510210 [Primary]
GS180726893510216 [Unit of Use]

FDA Product Code

HISCondom

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-03-28
Device Publish Date2020-06-02

Devices Manufactured by GLOBAL PROTECTION CORP.

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