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Revanesse Versa 1.2 mL

FDA UDI

by Prollenium Medical

Identity

Trade Name
Revanesse Versa 1.2 mL FDA UDI
Generic Name
Dermal tissue reconstructive material, synthetic polymer, bioabsorbable FDA UDI
Device Name
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 1.2 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. FDA UDI
Model / Reference
40089 FDA UDI
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 1.2 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. FDA UDI

Identifiers

Primary DI / UDI-DI
10669808001021 FDA UDI
GMDN Term
Dermal tissue reconstructive material, synthetic polymer, bioabsorbable FDA UDI

Classification

Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Dermal tissue reconstructive material, synthetic polymer, bioabsorbable

Revanesse Versa 1.2 mL by Prollenium Medical — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dermal tissue reconstructive material, synthetic polymer, bioabsorbable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Prollenium Medical

Sources (1)

  • FDA UDI a8384673-d626-46fe-82fb-1d5a78a7e3d9 33 fields · synced May 30, 2026