PRUDENCE BANANA

GUDID 20812420030185

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 ID20812420030185
NIH Device Record Key7fa0b369-95fe-4921-a355-223c999f642b
Commercial Distribution StatusIn Commercial Distribution
Brand NamePRUDENCE BANANA
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 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
GS100812420030235 [Unit of Use]
GS120812420030185 [Primary]

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

On-Brand Devices [PRUDENCE BANANA]

20812420030185Contraceptive, condom, male Basic male condom, Hevea-latex A Hevea-latex rubber sheath intended
10812420030188Contraceptive, condom, male Basic male condom, Hevea-latex A Hevea-latex rubber sheath intended
00812420030181Contraceptive, condom, male Basic male condom, Hevea-latex A Hevea-latex rubber sheath intended

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