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 Lift thread, bioabsorbable Lift thread, bioabsorbable Lift thread, bioabsorbable Lift thread, bioabsorbable Lift thread, bioabsorbable Lift thread, bioabsorbable Lift thread, bioabsorbable Lift thread, bioabsorbable Lift thread, bioabsorbable Lift thread, bioabsorbable 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