Duns Number:017003388
Device Description: Silhouette Lift suture is a non-absorbable polypropylene suture with an implantable grade 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.
Catalog Number
-
Brand Name
Silhouette Lift
Version/Model Number
SMS 03-PP-3.0.1-CL
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 31, 2016
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K060414,K171005,K060414,K171005,K060414,K171005,K060414,K171005
Product Code
GAM
Product Code Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
Public Device Record Key
c834d3ac-56fa-4f63-b680-7a271e8a3b71
Public Version Date
May 23, 2022
Public Version Number
7
DI Record Publish Date
September 24, 2015
Package DI Number
5060033040225
Quantity per Package
10
Contains DI Package
05060033040218
Package Discontinue Date
March 31, 2016
Package Status
Not in Commercial Distribution
Package Type
Dispenser Box