Duns Number:017003388
Device Description: The Silhouette Instalift device consists of two 304 Stainless Steel Surgical needles and a 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.
Catalog Number
-
Brand Name
Silhouette Instalift
Version/Model Number
SMS 30-PLG-3.0.1-NA
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K142061,K163676,K200140,K142061,K163676,K200140,K142061,K163676,K200140,K142061,K163676,K200140
Product Code
GAM
Product Code Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
Public Device Record Key
53739cdb-1343-4047-a81d-571d625814fc
Public Version Date
May 23, 2022
Public Version Number
7
DI Record Publish Date
September 24, 2015
Package DI Number
05060033040164
Quantity per Package
5
Contains DI Package
05060033040157
Package Discontinue Date
July 12, 2018
Package Status
Not in Commercial Distribution
Package Type
Dispenser Box