KY Intense Condoms

GUDID 20679810872509

Condom

RB Health (us) LLC

Basic male condom, Hevea-latex
Primary Device ID20679810872509
NIH Device Record Keyc0652918-6e86-45c5-89e4-5ca7850f4655
Commercial Distribution StatusIn Commercial Distribution
Brand NameKY Intense Condoms
Version Model NumberCondom
Company DUNS081049410
Company NameRB Health (us) LLC
Device Count12
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does n
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100679810872505 [Primary]
GS110679810872502 [Unit of Use]
GS120679810872509 [Package]
Contains: 00679810872505
Package: Carton [18 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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-12-13
Device Publish Date2018-10-31

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