Premium Rubber Helmet Condoms

Basic Information

• Brand Name: Premium Rubber Helmet Condoms
• Primary DI: 00850016109149
• Version / Model: RH10024
• Company Name: Scutagli, LLC
• Labeler DUNS: 078668294
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 24
• Record Status: Published
• Publish Date: 2023-08-25
• Public Version: 1
• Public Version Date: 2023-09-04
• Public Version Status: New
• Public Device Record Key: 9a0d5d04-bcc1-4b16-9596-b9dbfd5e2759

Device Description

Premium Rubber Helmet Condoms Aegis 49 Lubricated Latex Condoms - 24 Bulk Count

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HIS	Condom	Obstetrics/Gynecology	884.5300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45138	Basic male condom, Hevea-latex	A Hevea-latex rubber sheath intended to completely cover the penis during coitus to prevent sperm from gaining access to the female reproductive tract and/or prevent the transmission of sexually transmitted infections (STI). It may be textured, flavoured or contain lubricants. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00850016109156	GS1
Primary	00850016109149	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K994095	000