Prollenium Medical

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Cannula, Surgical, General & Plastic Surgery (GEA) (6)

Premarket Exempt

No Yes

Clear

Revanesse Versa 1.0mL - 10669808001007 Catalog Number :

Device Description : Revanesse Versa is manufactured by Prollenium Medical Technologies, and is a bio 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.

Device Class :

Duns Number: 247326606

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Revanese Versa+ with Lidocaine 1.0 mL - 10669808001014 Catalog Number :

Device Description : Revanesse Versa+ with Lidocaine (0.3% w/w) is manufactured by Prollenium Medical Revanesse Versa+ with Lidocaine (0.3% w/w) 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 contains two 1.0 mL syringes of Revanesse Versa+ with Lidocaine along with two sterile needles. Revanesse Versa+ with Lidocaine 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.

Device Class :

Duns Number: 247326606

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Revanese Versa 1.2 mL - 10669808001021 Catalog Number :

Device Description : Revanesse Versa is manufactured by Prollenium Medical Technologies, and is a bio 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.

Device Class :

Duns Number: 247326606

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Revanesse Versa+ with Lidocaine 1.2 mL - 10669808001038 Catalog Number :

Device Description : Revanesse Versa+ with Lidocaine (0.3% w/w) is manufactured by Prollenium Medical Revanesse Versa+ with Lidocaine (0.3% w/w) 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 contains two 1.2 mL syringes of Revanesse Versa+ with Lidocaine along with two sterile needles. Revanesse Versa+ with Lidocaine 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.

Device Class :

Duns Number: 247326606

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

MICROFILL 22G x 50mm - 10669808002004 Catalog Number :

Device Description : Sterile, single-use, stainless-steel cannula. Dimensions 22G x 50mm.

Device Class :

Duns Number: 247326606

Premarket Exempt : Yes

Product Code : GEA

Prescription Use : Yes

Device Count : 100

MICROFILL 22G x 70mm - 10669808002011 Catalog Number :

Device Description : Sterile, single-use, stainless-steel cannula. Dimensions 22G x 70mm.

Device Class : 1

Duns Number: 247326606

Premarket Exempt : Yes

Product Code : GEA

Prescription Use : Yes

Device Count : 100

MICROFILL 25G x 38mm - 10669808002028 Catalog Number :

Device Description : Sterile, single-use, stainless-steel cannula. Dimensions 25G x 38mm.

Device Class : 1

Duns Number: 247326606

Premarket Exempt : Yes

Product Code : GEA

Prescription Use : Yes

Device Count : 100

MICROFILL 25G x 50mm - 10669808002035 Catalog Number :

Device Description : Sterile, single-use, stainless-steel cannula. Dimensions 25G x 50mm.

Device Class : 1

Duns Number: 247326606

Premarket Exempt : Yes

Product Code : GEA

Prescription Use : Yes

Device Count : 100

MICROFILL 27G x 25mm - 10669808002042 Catalog Number :

Device Description : Sterile, single-use, stainless-steel cannula. Dimensions 27G x 25mm.

Device Class : 1

Duns Number: 247326606

Premarket Exempt : Yes

Product Code : GEA

Prescription Use : Yes

Device Count : 100

MICROFILL 27G x 38mm - 10669808002059 Catalog Number :

Device Description : Sterile, single-use, stainless-steel cannula. Dimensions 27G x 38mm.

Device Class : 1

Duns Number: 247326606

Premarket Exempt : Yes

Product Code : GEA

Prescription Use : Yes

Device Count : 100

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