DUREX Avanti Bare- RealFeel Non-Latex Condom

GUDID 20302340894559

Condom

RB Health (us) LLC

Basic male condom, synthetic polymer
Primary Device ID20302340894559
NIH Device Record Key59758a5a-7065-4dc5-804c-32e8b3ed0329
Commercial Distribution StatusIn Commercial Distribution
Brand NameDUREX Avanti Bare- RealFeel Non-Latex Condom
Version Model NumberCondom
Company DUNS081049410
Company NameRB Health (us) LLC
Device Count3
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 Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+1(800)756-5488
Emailxxx@xxx.xxx
Phone+1(800)756-5488
Emailxxx@xxx.xxx
Phone+1(800)756-5488
Emailxxx@xxx.xxx
Phone+1(800)756-5488
Emailxxx@xxx.xxx
Phone+1(800)756-5488
Emailxxx@xxx.xxx
Phone+1(800)756-5488
Emailxxx@xxx.xxx
Phone+1(800)756-5488
Emailxxx@xxx.xxx
Phone+1(800)756-5488
Emailxxx@xxx.xxx
Phone+1(800)756-5488
Emailxxx@xxx.xxx
Phone+1(800)756-5488
Emailxxx@xxx.xxx
Phone+1(800)756-5488
Emailxxx@xxx.xxx
Phone+1(800)756-5488
Emailxxx@xxx.xxx
Phone+1(800)756-5488
Emailxxx@xxx.xxx
Phone+1(800)756-5488
Emailxxx@xxx.xxx
Phone+1(800)756-5488
Emailxxx@xxx.xxx
Phone+1(800)756-5488
Emailxxx@xxx.xxx
Phone+1(800)756-5488
Emailxxx@xxx.xxx
Phone+1(800)756-5488
Emailxxx@xxx.xxx
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
GS100302340894555 [Primary]
GS110302340894552 [Package]
Contains: 00302340894555
Package: Carton [6 Units]
In Commercial Distribution
GS120302340894559 [Package]
Contains: 10302340894552
Package: Case [24 Units]
In Commercial Distribution
GS140302340894553 [Unit of Use]
GS188302340894553 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MOLCondom, synthetic

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 Avanti Bare- RealFeel Non-Latex Condom]

10302340894576Condom
10302340894569Condom
20302340894559Condom

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