Silhouette Lift

Basic Information

• Brand Name: Silhouette Lift
• Primary DI: 05060033040232
• Version / Model: SMS 06-PP-3.0.1-B-L
• Company Name: Sinclair Pharma US Inc.
• Labeler DUNS: 017003388
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2015-09-24
• Public Version: 7
• Public Version Date: 2022-05-23
• Public Version Status: Update
• Public Device Record Key: e53acde7-14cb-45f0-98d5-d854083ab9eb
• Distribution End Date: 2020-11-30

Device Description

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 Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	878.4493	2
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	878.5010	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46860	Lift thread, partially-bioabsorbable	A sterile filament made of a non-bioabsorbable material (e.g., polypropylene) with bioabsorbable projections (e.g., cones) attached along its length intended to be surgically implanted typically during a cosmetic surgical procedure for alternative lifting (e.g., face, neck, breast). The device is inserted through dermis and tacked to deep fascia where the projections produce tension for elevation of the subdermis. It is available in a variety of lengths and may be supplied with a needle(s).	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	5060033040249	GS1	Dispenser Box	10	Not in Commercial Distribution	2015-08-31
Primary	05060033040232	GS1
Unit of Use	05060033040317	GS1
Package	05060033040249	GS1	Dispenser box	10	Not in Commercial Distribution	2015-08-31
Package	05060033042007	GS1	Dispenser Box	10	Not in Commercial Distribution	2020-11-30

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K060414	000
K171005	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 27 Degrees Celsius