Revanesse Versa+ with Lidocaine 1.2mL

GUDID 66980800001024

Revanesse Versa+ with Lidocaine (0.3% w/w) 1.2 mL is manufactured by Prollenium Medical Technologies, and is a biocompatible, sterile, injectable hydrogel based on bioresorbable cross-linked hyaluronan (HA) (22 – 28 mg / mL concentration). The gel is delivered in a pre-filled disposable glass syringe. Each box of Revanesse Versa+ with Lidocaine 1.2 mL contains two 1.2 mL syringes of Revanesse Versa+ with Lidocaine 1.2 mL along with two sterile needles. Revanesse Versa+ with Lidocaine 1.2 mL is injected by qualified, trained doctors into the dermis of patients, using a variety of techniques. The injections place a small portion of the gel beneath a crease or wrinkle in the skin and the augmentation of the tissue produces a smoothing effect on the surface.

Prollenium Medical

Dermal tissue reconstructive material, microbe-derived, anaesthetic

• Primary Device ID: 66980800001024
• NIH Device Record Key: 140526f0-998b-470b-840e-46b170df8a90
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Revanesse Versa+ with Lidocaine 1.2mL
• Version Model Number: 40083
• 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: 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	66980800001024 [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: 2019-06-27
• Device Publish Date: 2019-06-19

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