Silhouette Instalift

GUDID 05060033040140

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 ID05060033040140
NIH Device Record Key649900d8-c3f4-4335-80f1-811ae27f74aa
Commercial Distribution StatusIn Commercial Distribution
Brand NameSilhouette Instalift
Version Model NumberSMS 29-PLG-3.0.1-NA
Company DUNS017003388
Company NameSILHOUETTE LIFT, INC.
Device Count2
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone9517347701
Emailquality@sinclairpharma.com
Phone9517347701
Emailquality@sinclairpharma.com
Phone9517347701
Emailquality@sinclairpharma.com
Phone9517347701
Emailquality@sinclairpharma.com
Phone9517347701
Emailquality@sinclairpharma.com
Phone9517347701
Emailquality@sinclairpharma.com
Phone9517347701
Emailquality@sinclairpharma.com
Phone9517347701
Emailquality@sinclairpharma.com
Phone9517347701
Emailquality@sinclairpharma.com
Phone9517347701
Emailquality@sinclairpharma.com
Phone9517347701
Emailquality@sinclairpharma.com
Phone9517347701
Emailquality@sinclairpharma.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105060033040133 [Primary]
GS105060033040140 [Package]
Contains: 05060033040133
Package: Dispenser Box [5 Units]
Discontinued: 2018-06-11
Not in Commercial Distribution
GS105060033040263 [Unit of Use]
GS105060033041727 [Package]
Contains: 05060033040133
Package: Dispenser box [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GAMSuture, Absorbable, Synthetic, Polyglycolic Acid

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2018-11-22
Device Publish Date2015-09-24

On-Brand Devices [Silhouette Instalift]

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

Trademark Results [Silhouette Instalift]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SILHOUETTE INSTALIFT
SILHOUETTE INSTALIFT
87019765 5950448 Live/Registered
Sinclair Pharmaceuticals Limited
2016-04-29
SILHOUETTE INSTALIFT
SILHOUETTE INSTALIFT
86373714 5166796 Live/Registered
Sinclair Pharmaceuticals Limited
2014-08-21

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