Premium Rubber Helmet Condoms

GUDID 00850016109156

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

Scutagli, LLC

Basic male condom, Hevea-latex Basic male condom, Hevea-latex

• Primary Device ID: 00850016109156
• NIH Device Record Key: 9a0d5d04-bcc1-4b16-9596-b9dbfd5e2759
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Premium Rubber Helmet Condoms
• Version Model Number: RH10024
• Company DUNS: 078668294
• Company Name: Scutagli, LLC
• Device Count: 24
• 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

Customer Support Contacts

• Phone: 720-351-5879
• Email: emukai@scutagli.com
• Phone: 720-351-5879
• Email: emukai@scutagli.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850016109149 [Primary]
GS1	00850016109156 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K994095

FDA Product Code

• HIS: Condom

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-04
• Device Publish Date: 2023-08-25

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• 00850016109156: Premium Rubber Helmet Condoms Aegis 49 Lubricated Latex Condoms - 24 Bulk Count
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