Premium Rubber Helmet Condoms

GUDID 00850016109712

Basic male condom, Hevea-latex

Primary Device ID	00850016109712
NIH Device Record Key	bb127da0-90d6-44c1-9c87-ae4529493c44
Commercial Distribution Status	In Commercial Distribution
Brand Name	Premium Rubber Helmet Condoms
Version Model Number	SCLF-52050
Company DUNS	078668294
Company Name	Scutagli, LLC
Device Count	50
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	true
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00850016109705 [Primary]
GS1	00850016109712 [Unit of Use]

Condom

Steralize Prior To Use	false
Device Is Sterile	false

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00850016109156	Premium Rubber Helmet Condoms Aegis 49 Lubricated Latex Condoms - 24 Bulk Count
00850016109712	Lifestyles Snugger Fit with Premium Rubber Helmet Condoms Silver Pocket Case - 50 Bulk Count

Mark Image Registration \| Serial	Company Trademark Application Date
PREMIUM RUBBER HELMET CONDOMS 88454326 not registered Live/Pending	Scutagli, LLC 2019-05-31