Revanesse Versa+ with Lidocaine 1.2mL
- Primary DI
- 66980800001024
- Brand
- Revanesse Versa+ with Lidocaine 1.2mL
- Company
- Prollenium Medical
- Model
- 40083
- Device description
- 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.
- Published
- 2019-06-19
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| LMH | Implant, Dermal, For Aesthetic Use |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| LMH | Implant, Dermal, For Aesthetic Use | Unknown | 3 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| P160042 | 004 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 66980800001024 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 66980800001024 | 66980800001024 |
GMDN Terms#
| Term | Definition |
|---|---|
| Dermal tissue reconstructive material, microbe-derived, anaesthetic | A sterile, bioabsorbable, bacteria-derived substance intended to be injected into the dermis/hypodermis of the skin, lip submucosa, and/or for supraperiosteal administration 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 includes a local anaesthetic agent (e.g., lidocaine). It typically includes bacterial hyaluronic acid (HA) as the principal constituent and is typically preloaded in a disposable syringe; disposable needle(s)/cannula(e) dedicated to injection may be included. |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Storage Environment Temperature | 2 Degrees Celsius | 25 Degrees Celsius |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 247326606
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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