Revanesse Versa+ with Lidocaine

GUDID 66980800001017

Revanesse Versa+ with Lidocaine (0.3% w/w) is manufactured by Prollenium Medical Technologies, and is a biocompatible, sterile, injectable hydrogel ba

Prollenium Medical

Dermal tissue reconstructive material, microbe-derived, anaesthetic

• Primary Device ID: 66980800001017
• NIH Device Record Key: 51c52a0f-4b6a-4dab-98ac-cbb50c9982fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Revanesse Versa+ with Lidocaine
• Version Model Number: 40082
• Company DUNS: 247326606
• Company Name: Prollenium Medical
• 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: true
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	66980800001017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P160042

FDA Product Code

• LMH: Implant, Dermal, For Aesthetic Use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-12-31
• Device Publish Date: 2018-11-28

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