Silhouette Lift - Silhouette Lift suture is a non-absorbable - Sinclair Pharma US Inc.

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 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.

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More Product Details

Catalog Number

-

Brand Name

Silhouette Lift

Version/Model Number

SMS 02-PP-2.0.1-B

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 31, 2020

Issuing Agency

In GS1

Product Characteristics

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

K171005,K060414,K171005,K060414,K171005,K060414,K171005,K060414,K171005,K060414

Product Code Details

Product Code

GAM

Product Code Name

Suture, Absorbable, Synthetic, Polyglycolic Acid

Device Record Status

Public Device Record Key

d22db5ef-d276-4f19-8e75-801143e047aa

Public Version Date

May 23, 2022

Public Version Number

7

DI Record Publish Date

September 24, 2015

Additional Identifiers

Package DI Number

5060033040201

Quantity per Package

10

Contains DI Package

05060033040195

Package Discontinue Date

October 30, 2017

Package Status

Not in Commercial Distribution

Package Type

Dispenser Box