DUREX Performax Intense Condom

GUDID 40302340856810

Condom

RB Health (us) LLC

Basic male condom, Hevea-latex
Primary Device ID40302340856810
NIH Device Record Keyded8f5cc-24c8-47a6-87e1-9bcbffa6956a
Commercial Distribution StatusIn Commercial Distribution
Brand NameDUREX Performax Intense Condom
Version Model NumberCondom
Company DUNS081049410
Company NameRB Health (us) LLC
Device Count1000
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+1(800)756-5488
Emailxxx@xxx.xxx

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat

Device Identifiers

Device Issuing AgencyDevice ID
GS100302340856812 [Primary]
GS140302340856810 [Unit of Use]

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 Date2020-03-12
Device Publish Date2020-03-04

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40302340853277Condom

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