ONE Classic Select Urban Collection

GUDID 80726893111802

1,000 Lubricated Male Latex Condoms

GLOBAL PROTECTION CORP.

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Primary Device ID80726893111802
NIH Device Record Keya6c82ac9-328c-4bd7-a70d-23606d43364e
Commercial Distribution StatusIn Commercial Distribution
Brand NameONE Classic Select Urban Collection
Version Model Number11000CW
Company DUNS364614362
Company NameGLOBAL PROTECTION CORP.
Device Count1000
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
GS120726893111800 [Primary]
GS180726893111802 [Unit of Use]

FDA Product Code

QRZExternal Condom For Anal Intercourse Or Vaginal Intercourse

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-04-21
Device Publish Date2020-06-02

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