Device Description : SoftFil® Precision are sterile and single use injection kits containing:- 1 stai SoftFil® Precision are sterile and single use injection kits containing:- 1 stainless steel pre-hole needle in its protective cap,- 1 stainless steel, graduated blunt-tip needle (micro-cannula) 27G x 40 mm in its protective cap.
Device Class :
Duns Number: 247326606
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : SoftFil® Precision are sterile and single use injection kits containing:- 1 stai SoftFil® Precision are sterile and single use injection kits containing:- 1 stainless steel pre-hole needle in its protective cap,- 1 stainless steel, graduated blunt-tip needle (micro-cannula) 27G x 50 mm in its protective cap.
Device Class :
Duns Number: 247326606
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : SoftFil® Precision are sterile and single use injection kits containing:- 1 stai SoftFil® Precision are sterile and single use injection kits containing:- 1 stainless steel pre-hole needle in its protective cap,- 1 stainless steel, graduated blunt-tip needle (micro-cannula) 30G x 25 mm in its protective cap.
Device Class :
Duns Number: 247326606
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : Revanesse® Lips+ is manufactured by Prollenium Medical Technologies, and is a bi 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 1.0 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.
Device Class :
Duns Number: 247326606
Premarket Exempt : No
Prescription Use : Yes
Device Description : Revanesse® Lips+ is manufactured by Prollenium Medical Technologies, and is a bi 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.
Device Class : 3
Duns Number: 247326606
Premarket Exempt : No
Prescription Use : Yes