pjur MAN Extreme

GUDID 40827160112095

Silicone-based Personal Lubricant

Pjur Group Luxembourg SA

Sexual lubricant

• Primary Device ID: 40827160112095
• NIH Device Record Key: cf245d5d-8843-4b32-94ed-e05fcac5d613
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: pjur MAN Extreme
• Version Model Number: pjur MAN Extreme 100 ml - USA
• Company DUNS: 400744553
• Company Name: Pjur Group Luxembourg SA
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00827160112097 [Primary]
GS1	10827160112094 [Package]; Contains: 00827160112097; Package: pack [12 Units]; In Commercial Distribution
GS1	40827160112095 [Package]; Contains: 10827160112094; Package: case [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133233

FDA Product Code

• NUC: Lubricant, Personal

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: 2019-01-04
• Device Publish Date: 2018-12-04

On-Brand Devices [pjur MAN Extreme]

• 40827160112217: Silicone-based Personal Lubricant
• 40827160112095: Silicone-based Personal Lubricant