Silhouette Instalift

Basic Information

• Brand Name: Silhouette Instalift
• Primary DI: 05060033040157
• Version / Model: SMS 30-PLG-3.0.1-NA
• Company Name: Sinclair Pharma US Inc.
• Labeler DUNS: 017003388
• Distribution Status: 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: 53739cdb-1343-4047-a81d-571d625814fc

Device Description

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 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: MR Safe
• 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

GMDN Terms

Code	Name	Definition	Implantable	Status
46859	Lift thread, bioabsorbable	A sterile filament made of a bioabsorbable material [e.g., poly-L-lactide (PLLA), poly(lactic-co-glycolic acid) (PLGA)] with projections (e.g., barbs or cones) 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 dedicated disposable implantation tools (e.g., needle, cannula).	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05060033040164	GS1	Dispenser Box	5	Not in Commercial Distribution	2018-07-12
Primary	05060033040157	GS1
Unit of Use	05060033040270	GS1
Package	05060033041741	GS1	Dispenser box	5	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K142061	000
K163676	000
K200140	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 8 Degrees Celsius