Prudence Sensitive

GUDID 20812420030048

Basic male condom, Hevea-latex A Hevea-latex rubber sheath intended to completely cover the penis during coitus to prevent sperm from gaining access to the female reproductive tract and/or prevent the transmission of sexually transmitted infections (STI). It may be textured, flavoured or contain lubricants. This is a single-use device.

DKT de México, S.A. de C.V.

Basic male condom, Hevea-latex
Primary Device ID20812420030048
NIH Device Record Keyd4bb3e6f-3375-4b28-84c9-280eac7cd547
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrudence Sensitive
Version Model NumberCondom
Company DUNS814851960
Company NameDKT de México, S.A. de C.V.
Device Count48
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100812420030099 [Unit of Use]
GS120812420030048 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HISCondom

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-11-22
Device Publish Date2018-06-20

On-Brand Devices [Prudence Sensitive]

00812420030044Basic male condom, Hevea-latex A Hevea-latex rubber sheath intended to completely cover the peni
20812420030048Basic male condom, Hevea-latex A Hevea-latex rubber sheath intended to completely cover the peni

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