Revanesse Versa 1.0mL

Primary DI
10669808001007
Brand
Revanesse Versa 1.0mL
Company
Prollenium Medical
Model
40081
Device description
Revanesse Versa 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 contains two 1.0 mL syringes of Revanesse Versa along with two sterile needles. Revanesse Versa 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.
Published
2020-12-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10669808001007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1066980800100710669808001007

GMDN Terms#

Term, Definition table
TermDefinition
Dermal tissue reconstructive material, synthetic polymer, bioabsorbableA sterile, bioabsorbable, aqueous solution containing a chemically synthesized polymer (e.g., copolyamide) intended to be injected into the dermis/hypodermis of the skin to add volume by serving as a space-occupying supplement to the intercellular matrix of connective tissue (dermal filler), typically to correct cutaneous contour deformities (e.g., wrinkles, folds, scars) associated with aging, injury, or degenerative lesions; it does not include a local anaesthetic agent. The material is typically preloaded in a disposable syringe.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
247326606
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Model table
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10669808002059MICROFILL 27G x 38mmPN560462020-06-22
10669808002066MICROFILL 27G x 50mmPN560472020-06-22
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