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 ID66980800001024
NIH Device Record Key140526f0-998b-470b-840e-46b170df8a90
Commercial Distribution StatusIn Commercial Distribution
Brand NameRevanesse Versa+ with Lidocaine 1.2mL
Version Model Number40083
Company DUNS247326606
Company NameProllenium Medical
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS166980800001024 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LMHImplant, Dermal, For Aesthetic Use

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-27
Device Publish Date2019-06-19

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