PRUDENCE MIX C/12

GUDID 00812420030259

Contraceptive, condom, male 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 ID00812420030259
NIH Device Record Key6474eb9f-8185-4cec-9c67-0d0322208195
Commercial Distribution StatusIn Commercial Distribution
Brand NamePRUDENCE MIX C/12
Version Model NumberCondom
Company DUNS814851960
Company NameDKT de México, S.A. de C.V.
Device Count1
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 Batchfalse
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
GS100812420030204 [Package]
Package: Inner [12 Units]
In Commercial Distribution
GS100812420030259 [Primary]
GS110812420030201 [Package]
Contains: 00812420030204
Package: Inner [6 Units]
In Commercial Distribution
GS120812420030208 [Package]
Contains: 10812420030201
Package: Case [24 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

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 Date2020-01-29
Device Publish Date2020-01-21

Devices Manufactured by DKT de México, S.A. de C.V.

00812420030228 - PRUDENCE CLASSIC C/122020-02-24 Contraceptive, condom, male Basic male condom, Hevea-latex A Hevea-latex rubber sheath intended to completely cover the penis du
00812420030211 - PRUDENCE SENSITIVE C/122020-02-24 Contraceptive, condom, male Basic male condom, Hevea-latex A Hevea-latex rubber sheath intended to completely cover the penis du
00812420030242 - PRUDENCE MIX C/32020-02-24 Contraceptive, condom, male Basic male condom, Hevea-latex A Hevea-latex rubber sheath intended to completely cover the penis du
00812420030181 - PRUDENCE BANANA2020-01-29 Contraceptive, condom, male Basic male condom, Hevea-latex A Hevea-latex rubber sheath intended to completely cover the penis du
00812420030259 - PRUDENCE MIX C/122020-01-29Contraceptive, condom, male 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."
00812420030259 - PRUDENCE MIX C/122020-01-29 Contraceptive, condom, male Basic male condom, Hevea-latex A Hevea-latex rubber sheath intended to completely cover the penis du
10812420030188 - PRUDENCE BANANA2020-01-29 Contraceptive, condom, male Basic male condom, Hevea-latex A Hevea-latex rubber sheath intended to completely cover the penis du
20812420030185 - PRUDENCE BANANA2020-01-29 Contraceptive, condom, male Basic male condom, Hevea-latex A Hevea-latex rubber sheath intended to completely cover the penis du
10812420030010 - Prudence Mint2019-11-22 Basic male condom, Hevea-latex A Hevea-latex rubber sheath intended to completely cover the penis during coitus to prevent sperm

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