pjur Silicone Gel

GUDID 40827160112040

Silicone-based Personal Lubricant

Pjur Group Luxembourg SA

Sexual lubricant

• Primary Device ID: 40827160112040
• NIH Device Record Key: aeb2450f-236a-4e30-bb38-a1efbfe721c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: pjur Silicone Gel
• Version Model Number: pjur Silicone Gel 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	00827160112042 [Primary]
GS1	10827160112049 [Package]; Contains: 00827160112042; Package: pack [12 Units]; In Commercial Distribution
GS1	40827160112040 [Package]; Contains: 10827160112049; Package: case [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133336

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: 2017-05-01

Devices Manufactured by Pjur Group Luxembourg SA

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• 10827160116283 - pjur med SENSITIVE: 2024-05-08 Water-based Personal Lubricant
• 10827160116290 - pjur AQUA Natural: 2024-05-08 Water-based Personal Lubricant
• 10827160115255 - pjur INFINITY silicone-based: 2022-11-14 Silicone-based Personal Lubricant
• 10827160115262 - pjur INFINITY water-based: 2022-11-14 water-based Personal Lubricant
• 10827160115163 - pjur INFINITY silicone-based: 2022-10-03 Silicone-based Personal Lubricant
• 10827160115170 - pjur INFINITY water-based: 2022-10-03 water-based Personal Lubricant