pjur MED Repair glide

GUDID 40827160106308

Water-based Personal Lubricant with Hyaluron

Pjur Group Luxembourg SA

Sexual lubricant

• Primary Device ID: 40827160106308
• NIH Device Record Key: 3cf0a3fb-0bd3-4dfc-9155-859040ebde63
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: pjur MED Repair glide
• Version Model Number: pjur MED Repair glide 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	00827160106300 [Primary]
GS1	10827160106307 [Package]; Contains: 00827160106300; Package: pack [12 Units]; In Commercial Distribution
GS1	40827160106308 [Package]; Contains: 10827160106307; Package: case [12 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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-08-09
• Device Publish Date: 2017-07-14

On-Brand Devices [pjur MED Repair glide]

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