Silhouette Lift

GUDID 05060033040218

Silhouette Lift suture is a non-absorbable polypropylene suture with an implantable grade L-lactide/Glycolide (PLG-8218) resorbable based cone that ha

SILHOUETTE LIFT, INC.

Lift thread, partially-bioabsorbable Lift thread, partially-bioabsorbable Lift thread, partially-bioabsorbable Lift thread, partially-bioabsorbable Lift thread, partially-bioabsorbable Lift thread, partially-bioabsorbable Lift thread, partially-bioabsorbable Lift thread, partially-bioabsorbable Lift thread, partially-bioabsorbable Lift thread, partially-bioabsorbable Lift thread, partially-bioabsorbable Lift thread, partially-bioabsorbable

• Primary Device ID: 05060033040218
• NIH Device Record Key: c834d3ac-56fa-4f63-b680-7a271e8a3b71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silhouette Lift
• Version Model Number: SMS 03-PP-3.0.1-CL
• Company DUNS: 017003388
• Company Name: SILHOUETTE LIFT, INC.
• Device Count: 2
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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 27 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060033040218 [Primary]
GS1	05060033040225 [Package]; Package: Dispenser box [10 Units]; Discontinued: 2018-04-30; Not in Commercial Distribution
GS1	05060033040300 [Unit of Use]
GS1	5060033040225 [Package]; Package: Dispenser Box [10 Units]; Discontinued: 2018-04-30; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060414

FDA Product Code

• GAW: Suture, Nonabsorbable, Synthetic, Polypropylene

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 Lift]

• 5060033040249: Silhouette Lift suture is a non-absorbable polypropylene suture with an implantable grade L-lact
• 05060033040218: Silhouette Lift suture is a non-absorbable polypropylene suture with an implantable grade L-lact
• 5060033040201: Silhouette Lift suture is a non-absorbable polypropylene suture with an implantable grade L-lact
• 5060033040188: Silhouette Lift suture is a non-absorbable polypropylene suture with an implantable grade L-lact