SKYN 90202

GUDID 00792554902021

SKYN Elite Large Non-Latex Condom, 3ct

Lil' Drug Store Products, Inc.

Basic male condom, synthetic polymer
Primary Device ID00792554902021
NIH Device Record Key57b0a5ce-da5b-44bd-bb3c-22ff38a26a05
Commercial Distribution StatusIn Commercial Distribution
Brand NameSKYN
Version Model Number210124
Catalog Number90202
Company DUNS093103646
Company NameLil' Drug Store Products, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100792554902021 [Primary]

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 Date2022-09-20
Device Publish Date2022-09-12