Revanesse Versa+ with Lidocaine 1.2 mL

GUDID 10669808001038

Revanesse Versa+ with Lidocaine (0.3% w/w) 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 contains two 1.2 mL syringes of Revanesse Versa+ with Lidocaine along with two sterile needles. Revanesse Versa+ with Lidocaine 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: 10669808001038
• NIH Device Record Key: da437f67-78e3-43bf-8124-ebacd48fbb02
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Revanesse Versa+ with Lidocaine 1.2 mL
• 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: true
• Device Combination Product: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10669808001038 [Primary]

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: 2020-12-23
• Device Publish Date: 2020-12-15

Devices Manufactured by Prollenium Medical

• 10669808002394 - SoftFil® EasyGuide: 2022-08-19 SoftFil® EasyGuide is a sterile and single use injection kit containing: - 1 stainless steel EasyGuide pre-hole needle in its p
• 10669808002400 - SoftFil® EasyGuide: 2022-08-19 SoftFil® EasyGuide is a sterile and single use injection kit containing: - 1 stainless steel EasyGuide pre-hole needle in its p
• 10669808002417 - SoftFil® EasyGuide: 2022-08-19 SoftFil® EasyGuide is a sterile and single use injection kit containing: - 1 stainless steel EasyGuide pre-hole needle in its p
• 10669808002424 - SoftFil® EasyGuide: 2022-08-19 SoftFil® EasyGuide is a sterile and single use injection kit containing: - 1 stainless steel EasyGuide pre-hole needle in its p
• 10669808002431 - SoftFil® EasyGuide: 2022-08-19 SoftFil® EasyGuide is a sterile and single use injection kit containing: - 1 stainless steel EasyGuide pre-hole needle in its p
• 10669808002448 - SoftFil® EasyGuide: 2022-08-19 SoftFil® EasyGuide is a sterile and single use injection kit containing: - 1 stainless steel EasyGuide pre-hole needle in its p
• 10669808002455 - SoftFil® EasyGuide: 2022-08-19 SoftFil® EasyGuide is a sterile and single use injection kit containing: - 1 stainless steel EasyGuide pre-hole needle in its p
• 10669808002462 - SoftFil® EasyGuide: 2022-08-19 SoftFil® EasyGuide is a sterile and single use injection kit containing: - 1 stainless steel EasyGuide pre-hole needle in its p