RUGBY 370-092

GUDID 20305369995122

Premium Lubricated Latex Condoms 1 each

Rugby Laboratories

Basic male condom, Hevea-latex

• Primary Device ID: 20305369995122
• NIH Device Record Key: 41866584-788b-4ac3-845a-bbd761261bd7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RUGBY
• Version Model Number: 370-092
• Catalog Number: 370-092
• Company DUNS: 079246066
• Company Name: Rugby Laboratories
• Device Count: 1
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00305369995128 [Package]; Contains: 80305369995124; Package: BOX [12 Units]; In Commercial Distribution
GS1	20305369995122 [Package]; Contains: 00305369995128; Package: PACK [12 Units]; In Commercial Distribution
GS1	30305369995129 [Package]; Package: CASE [12 Units]; In Commercial Distribution
GS1	80305369995124 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K896987

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: 2021-06-21
• Device Publish Date: 2021-06-11

On-Brand Devices [RUGBY]

• 50305361119329: Rugby Sheer Adhesive Bandages 3/4in x 3in 200 each
• 50880681034007: Rugby Sheer Adhesive Bandages 3/4in x 3in 200 each
• 20305369995122: Premium Lubricated Latex Condoms 1 each