KY Extra Lubricated Condoms

GUDID 00067981087192

Condom

RB Health (us) LLC

Basic male condom, Hevea-latex
Primary Device ID00067981087192
NIH Device Record Keyd6497e0b-b6cc-43b3-809a-ca890b7b543f
Commercial Distribution StatusIn Commercial Distribution
Brand NameKY Extra Lubricated Condoms
Version Model NumberCondom
Company DUNS081049410
Company NameRB Health (us) LLC
Device Count48
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
GS100067981087192 [Primary]
GS110067981087199 [Package]
Package: Carton [9 Units]
In Commercial Distribution
GS140067981087190 [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 Number3
Public Version Date2019-10-15
Device Publish Date2018-10-31

On-Brand Devices [KY Extra Lubricated Condoms]

10679810871901Condom
10679810871802Condom
10679810871703Condom
00067981087185Condom
00067981087178Condom
10067981087755Condom
00067981087192Condom

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