FDA.reportPublic FDA data

Silhouette Lift

Primary DI
5060033040249
Brand
Silhouette Lift
Company
SILHOUETTE LIFT, INC.
Model
SMS 06-PP-3.0.1-B-L
Device description
Silhouette Lift suture is a non-absorbable polypropylene suture with an implantable grade L-lactide/Glycolide (PLG-8218) resorbable based cone that ha
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAMSuture, Absorbable, Synthetic, Polyglycolic Acid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAMSuture, Absorbable, Synthetic, Polyglycolic AcidGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060414000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060414000KOLSTER METHODS, INC., FEATHERLIFT SILHOUETTE SUTUREKmi Kolster Methods, Inc.2006-10-23GAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060033040249PackageGS110Not in Commercial Distribution
05060033042007PackageGS110In Commercial Distribution
5060033040249PackageGS110Not in Commercial Distribution
05060033040232PrimaryGS10
05060033040317Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060033040249050600330402495060033040249
05060033042007050600330420075060033042007
05060033040232050600330402325060033040232
05060033040317050600330403175060033040317

GMDN Terms#

Term, Definition table
TermDefinition
Lift thread, partially-bioabsorbableA 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).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius27 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9517347701quality@sinclairpharma.com

Regulatory Flags#

DUNS number
017003388
Device count
2
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060033040102Silhouette InstaliftSMS 28-PLG-3.0.1-NA2015-09-24
05060033040140Silhouette InstaliftSMS 29-PLG-3.0.1-NA2015-09-24
05060033040164Silhouette InstaliftSMS 30-PLG-3.0.1-NA2015-09-24
5060033040188Silhouette Lift SMS 01-PP-3.0.1-B-S2015-09-24
5060033040201Silhouette LiftSMS 02-PP-2.0.1-B2015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08904255234383PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
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