pjur MED Repair glide

GUDID 40827160111142

Water-based Personal Lubricant

Pjur Group Luxembourg SA

Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant

• Primary Device ID: 40827160111142
• NIH Device Record Key: 84d2e33a-6305-4501-a30b-81248daa9649
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: pjur MED Repair glide
• Version Model Number: pjur MED Repair glide 2 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	00827160111144 [Primary]
GS1	10827160111141 [Package]; Contains: 00827160111144; Package: pack [50 Units]; In Commercial Distribution
GS1	40827160111142 [Package]; Contains: 10827160111141; Package: case [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010199

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 MED Repair glide]

• 40827160111142: Water-based Personal Lubricant
• 40827160106308: Water-based Personal Lubricant with Hyaluron