Address:13900 W. Grandview Parkway,Sturtevant,WI,53177,US
Device Description : Individually packaged DeScribe PFD Patch (each)Contains 5 DeScribe PFD Patches.
Device Class : 2
Duns Number: 028147846
Premarket Exempt : No
Prescription Use : Yes
Device Description : Individually packaged DeScribe PFD Patch (each)
Device Class :
Duns Number: 028147846
Premarket Exempt : No
Prescription Use : Yes
Device Description : Individually packaged DeScribe PFD Patch (each). Contains 2 Describe PFD Patches.
Device Class : 2
Duns Number: 028147846
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Coaptite Injectable Implant is a permanently implanted device used to treat The Coaptite Injectable Implant is a permanently implanted device used to treat women who have severe stress urinary incontinence due to poorly functioning urethral sphincter muscles.
Device Class : 3
Duns Number: 028147846
Premarket Exempt : No
Prescription Use : Yes
Device Description : Prolaryn Plus is a water based injectable gel implant used to treat vocal fold i Prolaryn Plus is a water based injectable gel implant used to treat vocal fold insufficiency. The principle component of Prolaryn Plus is synthetic calcium hydroxyapatite, a biomaterial found in bone and teeth. Injection with Prolaryn Plus augments or bulks ups the displaced or damaged vocal fold so that it can improve speaking. The result is long term restoration and augmentation. Prolaryn Plus can be injected with a 26 gauge or larger diameter thin-wall-needle.
Device Class : 2
Duns Number: 028147846
Premarket Exempt : No
Prescription Use : Yes
Device Description : Radiesse (+) Lidocaine 1.5cc Injectable Implant is a volumizing filler with inte Radiesse (+) Lidocaine 1.5cc Injectable Implant is a volumizing filler with integral lidocaine indicated for subdermal implamantation for the correction of moderate to severe folds, such as nasolabial folds. Radiesse (+) Kit contains (1) 1.5cc Injectable Implant and (2) 27 gauge thin walled x 0.75" needles.
Device Class : 3
Duns Number: 028147846
Premarket Exempt : No
Prescription Use : Yes
Device Description : Radiesse (+) Lidocaine 1.5cc Injectable Implant is a volumizing filler with inte Radiesse (+) Lidocaine 1.5cc Injectable Implant is a volumizing filler with integral lidocaine indicated for subdermal implamantation for the correction of moderate to severe folds, such as nasolabial folds. Radiesse (+) Kit contains (2) 1.5cc Injectable Implant and (4) 27 gauge thin walled x 0.75" needles.
Device Class :
Duns Number: 028147846
Premarket Exempt : No
Prescription Use : Yes
Device Description : Radiesse (+) Lidocaine Injectable Implant is a volumizing filler with lidocaine Radiesse (+) Lidocaine Injectable Implant is a volumizing filler with lidocaine indicated for subdermal implamantation for the correction of moderate to severe folds, such as nasolabial folds. Radiesse (+) Kit contains (1) 0.8cc Injectable Implant and (2) 27 gauge thin walled x 0.75" needles.
Device Class : 3
Duns Number: 028147846
Premarket Exempt : No
Prescription Use : Yes
Device Description : Radiesse Injectable Implant is a volumizing filler indicated for subdermal impla Radiesse Injectable Implant is a volumizing filler indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds and it is also intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. Radiesse Volumizing Filler Kit contains (1) injectable implant and (2) 27 gauge thin walled x 0.75 inch needles.
Device Class : 3
Duns Number: 028147846
Premarket Exempt : No
Prescription Use : Yes
Device Description : Radiesse Injectable Implant is a volumizing filler indicated for subdermal impla Radiesse Injectable Implant is a volumizing filler indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds and it is also intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. Radiesse Volumizing Filler Kit contains (1) injectable implant and (2) 27 gauge thin walled x 0.75 inch needles. RADIESSE injectable implant is also indicated for hand augmentation to correct volume loss in the dorsum of the hands.
Device Class : 3
Duns Number: 028147846
Premarket Exempt : No
Prescription Use : Yes