DUREX Invisible Condom

GUDID 20302340912772

Condom

RB Health (us) LLC

Basic male condom, Hevea-latex
Primary Device ID20302340912772
NIH Device Record Key53fe8f48-e199-4c2a-8120-a03b1c751a04
Commercial Distribution StatusIn Commercial Distribution
Brand NameDUREX Invisible Condom
Version Model NumberCondom
Company DUNS081049410
Company NameRB Health (us) LLC
Device Count8
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
GS100302340912778 [Primary]
GS110302340912775 [Package]
Contains: 00302340912778
Package: Carton [3 Units]
In Commercial Distribution
GS120302340912772 [Package]
Contains: 10302340912775
Package: Case [16 Units]
In Commercial Distribution
GS140302340912776 [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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-12-13
Device Publish Date2016-09-20

On-Brand Devices [DUREX Invisible Condom]

10302340912782Condom
20302340912772Condom
20302340912765Condom
10302340983553Condom

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.