Identity
- Trade Name
- Revanesse Versa 1.0mL 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 1.0 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. FDA UDI
- Model / Reference
- 40081 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 1.0 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10669808001007 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 1.0mL 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
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Manufacturer
- Manufacturer
- Prollenium Medical
Sources (1)
- FDA UDI 30f65d1e-cbff-4952-8365-14f18b6f0a85 33 fields · synced May 30, 2026