Silhouette Instalift

GUDID 05060033040102

The Silhouette Instalift device consists of two 304 Stainless Steel Surgical needles and an absorbable implant. The absorbable implant consists of a s

SILHOUETTE LIFT, INC.

Lift thread, bioabsorbable

• Primary Device ID: 05060033040102
• NIH Device Record Key: 548a9503-32ac-417b-9133-0fa8a41351f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silhouette Instalift
• Version Model Number: SMS 28-PLG-3.0.1-NA
• Company DUNS: 017003388
• Company Name: SILHOUETTE LIFT, INC.
• Device Count: 2
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 9517347701
• Email: quality@sinclairpharma.com
• Phone: 9517347701
• Email: quality@sinclairpharma.com
• Phone: 9517347701
• Email: quality@sinclairpharma.com
• Phone: 9517347701
• Email: quality@sinclairpharma.com
• Phone: 9517347701
• Email: quality@sinclairpharma.com
• Phone: 9517347701
• Email: quality@sinclairpharma.com
• Phone: 9517347701
• Email: quality@sinclairpharma.com
• Phone: 9517347701
• Email: quality@sinclairpharma.com
• Phone: 9517347701
• Email: quality@sinclairpharma.com
• Phone: 9517347701
• Email: quality@sinclairpharma.com
• Phone: 9517347701
• Email: quality@sinclairpharma.com
• Phone: 9517347701
• Email: quality@sinclairpharma.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060033040096 [Primary]
GS1	05060033040102 [Package]; Contains: 05060033040096; Package: Dispenser Box [5 Units]; Discontinued: 2018-05-31; Not in Commercial Distribution
GS1	05060033040256 [Unit of Use]
GS1	05060033041703 [Package]; Contains: 05060033040096; Package: Dispenser box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142061

FDA Product Code

• GAM: Suture, Absorbable, Synthetic, Polyglycolic Acid

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-11-22
• Device Publish Date: 2015-09-24

On-Brand Devices [Silhouette Instalift]

• 05060033040164: The Silhouette Instalift device consists of two 304 Stainless Steel Surgical needles and an abso
• 05060033040140: The Silhouette Instalift device consists of two 304 Stainless Steel Surgical needles and an abso
• 05060033040102: The Silhouette Instalift device consists of two 304 Stainless Steel Surgical needles and an abso