KY Intense Condoms

GUDID 20067981087264

Condom

RB Health (us) LLC

Basic male condom, Hevea-latex
Primary Device ID20067981087264
NIH Device Record Key9c6c363e-26e2-4dd4-b4c9-b9188ab9061a
Commercial Distribution StatusIn Commercial Distribution
Brand NameKY Intense Condoms
Version Model NumberCondom
Company DUNS081049410
Company NameRB Health (us) LLC
Device Count24
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
GS100067981087260 [Primary]
GS110067981087267 [Package]
Contains: 00067981087260
Package: Carton [3 Units]
In Commercial Distribution
GS120067981087264 [Package]
Contains: 10067981087267
Package: Case [6 Units]
In Commercial Distribution
GS140067981087268 [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 Date2019-06-07
Device Publish Date2019-05-30

On-Brand Devices [KY Intense Condoms]

20679810872707Condom
20679810872608Condom
20679810872509Condom
20067981087264Condom
10067981087250Condom
20067981087769Condom
10067981087274Condom

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