FDA.reportPublic FDA data

Revanesse Lips+ with Lidocaine 1.2 mL

Primary DI
10669808003032
Brand
Revanesse Lips+ with Lidocaine 1.2 mL
Company
Prollenium Medical
Model
40149
Device description
Revanesse® Lips+ is manufactured by Prollenium Medical Technologies, and is a biocompatible, biodegradable, non-pyrogenic, sterile, injectable viscoelastic clearcolorless hydrogel based on bioresorbable BDDE cross-linked hyaluronan (HA) (22 – 28 mg / mL concentration) containing 0.3% lidocaine. The HA is produced by theStreptococcus species of bacteria. The gel is delivered in a pre-filled disposable glass syringe. Each syringe is fitted with a Luer lock adaptor, a plunger rod, a rubber stopper tip cap, and a finger grip. Each box of Revanesse® Lips+ contains two 1.2 mL syringes of Revanesse® Lips+ along with two 0.5-inch 30-gauge sterile needles. The syringe is labeled with the product name, the manufacturer, lot number, and expiration date. There is a removable portion of the label, which can be affixed to the patient record.
Published
2021-05-17
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

Product Codes#

Code, Name table
CodeName
LMHImplant, Dermal, For Aesthetic Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LMHImplant, Dermal, For Aesthetic UseUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P160042014

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P160042014REVANESSE ULTRAProllenium Medical Technologies, Inc.2017-08-04LMH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10669808003032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1066980800303210669808003032

GMDN Terms#

Term, Definition table
TermDefinition
Dermal tissue reconstructive material, microbe-derived, anaestheticA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10669808005791Revanesse Gel PackPN998022025-05-22
10669808004008SoftFil® EasyGuideCEGS2550U2025-08-28
10669808004084SoftFil® PrecisionCP2550U2025-08-28
10669808002141SoftFil® EasyGuideCEGS2550U2025-08-28
10669808002325SoftFil® PrecisionCP2550U2025-08-28
10669808002011MICROFILL 22G x 70mmPN560422020-06-22
10669808002028MICROFILL 25G x 38mmPN560432020-06-22
10669808002035MICROFILL 25G x 50mmPN560442020-06-22
10669808002042MICROFILL 27G x 25mmPN560452020-06-22
10669808002059MICROFILL 27G x 38mmPN560462020-06-22
10669808002066MICROFILL 27G x 50mmPN560472020-06-22
10669808002073MICROFILL 30G x 25mmPN560482020-06-22
10669808002080MICROFILL 30G x 40mmPN560492020-06-22
10669808002004MICROFILL 22G x 50mmPN560412020-06-22
10669808001007Revanesse Versa 1.0mL400812020-12-15
10669808001014Revanesse Versa+ with Lidocaine 1.0 mL400822020-12-15
10669808001021Revanesse Versa 1.2 mL400892020-12-15
10669808002394SoftFil® EasyGuideCEGS2250U2022-08-11
10669808002400SoftFil® EasyGuideCEGS2330U2022-08-11
10669808002417SoftFil® EasyGuideCEGS2350U2022-08-11

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