WINK CLOSER

GUDID 00028373140246

WINK Closer Condom (24ct box)

OKAMOTO USA, INC.

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Primary Device ID00028373140246
NIH Device Record Key9f850679-a294-4cd3-995f-889b3e054ff1
Commercial Distribution StatusIn Commercial Distribution
Brand NameWINK CLOSER
Version Model Number14024
Company DUNS175752724
Company NameOKAMOTO USA, INC.
Device Count24
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-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100028373140246 [Primary]
GS180028373140242 [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 Date2023-07-25
Device Publish Date2019-10-04

On-Brand Devices [WINK CLOSER]

00028373140246WINK Closer Condom (24ct box)
00028373140109WINK Closer Condom (10ct box)
00028373140031WINK Closer Condom (3ct box)

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