Royal

GUDID 00850012584148

M3 Global Enterprises, LLC

Basic male condom, Hevea-latex

• Primary Device ID: 00850012584148
• NIH Device Record Key: 5ba6b311-e796-41a9-900b-8511ef558a37
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Royal
• Version Model Number: Royal Chocolate Condoms Box of 3
• Company DUNS: 080373674
• Company Name: M3 Global Enterprises, LLC
• 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: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00850012584148 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161195

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: 2019-10-29
• Device Publish Date: 2019-10-21

On-Brand Devices [Royal]

• 00646437668996: Royal Strawberry Condoms Box of 20
• 00646437668989: Royal Chocolate Condoms Box of 20
• 00646437668958: Royal Strawberry Condoms Box of 3
• 00646437668910: Royal Coffee Condoms Box of 20
• 00646437668903: Royal Natural Condoms Box of 3
• 00646437668897: Royal Black Grape Condoms Box of 3
• 00646437668880: Royal Coffee Condoms Box of 3
• 00646437668873: Royal Chocolate Condoms Box of 3
• 00646437668866: Royal Natural Condoms Box of 10
• 00646437668859: Royal Black Grape Condoms Box of 10
• 00646437668835: Royal Strawberry Condoms Box of 10
• 00646437668828: Royal Chocolate Condoms Box of 10
• 00646437668811: Royal Natural Condoms Box of 20
• 00646435669009: Royal Black Grape Condoms Box of 20
• 00850012584155: Royal Chocolate Condoms Box of 20
• 00850012584148: Royal Chocolate Condoms Box of 3
• 00850012584131: Royal Chocolate Condoms Box of 10
• 00850012584124: Royal Strawberry Condoms Box of 20
• 00850012584117: Royal Strawberry Condoms Box of 3
• 00850012584100: Royal Strawberry Condoms Box of 10
• 00850012584018: Royal Natural Condoms Box of 10
• 00850012584001: Royal Natural Condoms Box of 3
• 00850012584179: Royal Ultra Thin Natural XL Condoms Box of 10
• 00850012584162: Royal Ultra Thin Natural XL Condoms Box of 20
• 00850012584032: Royal Ultra Thin Natural Condoms Box of 10
• 00850012584025: Royal Ultra Thin Natural Condoms Box of 20
• 00850012584445: Royal Strawberry Condoms Box of 12