Harmony Latex Dam Retail Pack

GUDID 00628347069810

Harmony Latex Dam Retail Pack 6/pack

Pamco Distributing Inc

Female condom, synthetic polymer
Primary Device ID00628347069810
NIH Device Record Keybbdaa0ae-d1c7-47dd-973e-2bef5f68e250
Commercial Distribution StatusIn Commercial Distribution
Brand NameHarmony Latex Dam Retail Pack
Version Model NumberHA-202-R
Company DUNS208394130
Company NamePamco Distributing Inc
Device Count6
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100628347069810 [Primary]
GS100860003804551 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MSCBarrier, Std, Oral Sex

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-04-02
Device Publish Date2022-02-17

On-Brand Devices [Harmony Latex Dam Retail Pack]

00860003804537Harmony Latex Dam Retail Pack 6/pack
00628347069810Harmony Latex Dam Retail Pack 6/pack

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