myONE O17

GUDID 80726893510384

6 Lubricated Male latex condoms

GLOBAL PROTECTION CORP.

Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex
Primary Device ID80726893510384
NIH Device Record Keyfdf5e59d-624e-42ec-aefe-027ee80ee55f
Commercial Distribution StatusIn Commercial Distribution
Brand NamemyONE O17
Version Model NumberMYONE-O17-6
Company DUNS364614362
Company NameGLOBAL PROTECTION CORP.
Device Count6
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 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
GS100726893510388 [Primary]
GS180726893510384 [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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80813686021711 - Dame2024-03-26 Dame Ultra Thin Condoms- 12 count pack- Lubricated latex condoms
80726893116906 - ONE Super sensitive2024-03-06 ONE super sensitive- contest collection Bulk pack- 3000 pcs
20726893116720 - Trustex2024-02-19 Trustex Nitrile Exam Gloves, Large, box of 100
20726893116737 - Trustex2024-02-19 Trustex Nitrile Exam Gloves, Small, box of 100- Powder free Nitrile examination gloves
20726893116744 - Trustex2024-02-19 Trustex Nitrile Exam Gloves, Medium, box of 100- Powder free Nitrile examination gloves
80855770008567 - Maude2024-02-16 Maude Ultra Thin Lubricated Condom- pack of 10
20726893116898 - One2024-02-14 ONE Flex USA 36-count

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