Address:18 TECHNOLOGY DRIVE,Irvine,CA,92618,US
Device Description : The Silhouette Instalift device consists of two 304 Stainless Steel Surgical nee The Silhouette Instalift device consists of two 304 Stainless Steel Surgical needles and an absorbable implant. The absorbable implant consists of a single monofilament that holds two sets of 8 cones. Both the monofilament and the cones are made from 82:18 L-lactide/ Glycolide bioresorbable (PURAC LG 8218) resin material.
Device Class :
Duns Number: 017003388
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Silhouette Instalift device consists of two 304 Stainless Steel Surgical nee The Silhouette Instalift device consists of two 304 Stainless Steel Surgical needles and an absorbable implant. The absorbable implant consists of a single monofilament that holds two sets of 12 cones. Both the monofilament and the cones are made from 82:18 L-lactide/ Glycolide bioresorbable (PURAC LG 8218) resin material.
Device Class :
Duns Number: 017003388
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Silhouette Instalift device consists of two 304 Stainless Steel Surgical nee The Silhouette Instalift device consists of two 304 Stainless Steel Surgical needles and an absorbable implant. The absorbable implant consists of a single monofilament that holds two sets of 16 cones. Both the monofilament and the cones are made from 82:18 L-lactide/ Glycolide bioresorbable (PURAC LG 8218) resin material.
Device Class :
Duns Number: 017003388
Premarket Exempt : No
Prescription Use : Yes
Device Description : Silhouette Lift suture is a non-absorbable polypropylene suture with an implanta Silhouette Lift suture is a non-absorbable polypropylene suture with an implantable grade L-lactide/Glycolide (PLG-8218) resorbable based cone that has been injection molded to strict tolerances and affixed to the polypropylene base suture in a secondary operation without any modification or degradation to the base suture. This model number of Silhouette Lift suture is 40.5 cm in length, with a total of 6 molded cones fixed to the distal end of the suture. Silhouette Lift suture is indicated for use in mid-face suspension surgery to fixate the cheek dermis in an elevated position.
Device Class :
Duns Number: 017003388
Premarket Exempt : No
Prescription Use : Yes
Device Description : Silhouette Lift suture is a non-absorbable polypropylene suture with an implanta Silhouette Lift suture is a non-absorbable polypropylene suture with an implantable grade L-lactide/Glycolide (PLG-8218) resorbable based cone that has been injection molded to strict tolerances and affixed to the polypropylene base suture in a secondary operation without any modification or degradation to the base suture. This model number of Silhouette Lift suture is 37.3 cm in length, with a total of 10 molded cones fixed to the distal end of the suture. Silhouette Lift suture is indicated for use in mid-face suspension surgery to fixate the cheek dermis in an elevated position.
Device Class :
Duns Number: 017003388
Premarket Exempt : No
Prescription Use : Yes
Device Description : Silhouette Lift suture is a non-absorbable polypropylene suture with an implanta Silhouette Lift suture is a non-absorbable polypropylene suture with an implantable grade L-lactide/Glycolide (PLG-8218) resorbable based cone that has been injection molded to strict tolerances and affixed to the polypropylene base suture in a secondary operation without any modification or degradation to the base suture. This model number of Silhouette Lift suture is 40.5 cm in length, with a total of 6 molded cones fixed to the distal end of the suture. Silhouette Lift suture is indicated for use in mid-face suspension surgery to fixate the cheek dermis in an elevated position.
Device Class :
Duns Number: 017003388
Premarket Exempt : No
Prescription Use : Yes
Device Description : Silhouette Lift suture is a non-absorbable polypropylene suture with an implanta Silhouette Lift suture is a non-absorbable polypropylene suture with an implantable grade L-lactide/Glycolide (PLG-8218) resorbable based cone that has been injection molded to strict tolerances and affixed to the polypropylene base suture in a secondary operation without any modification or degradation to the base suture. This model number of Silhouette Lift suture is 40.5 cm in length, with a total of 6 molded cones fixed to the distal end of the suture along with a blunt needle. Silhouette Lift suture is indicated for use in mid-face suspension surgery to fixate the cheek dermis in an elevated position.
Device Class :
Duns Number: 017003388
Premarket Exempt : No
Prescription Use : Yes