SINCLAIR PHARMA US, INC.

Matched from indexed company URL: Sinclair Pharma US Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30070097553007009755SINCLAIR PHARMA US, INC.1N2026-01-0118 TECHNOLOGY DRIVE SUITE 134 Irvine CA US 92618

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
05060033040096Silhouette Instalift - The Silhouette Instalift device consists of two 304 Stainless Steel Surgical needles and an absorbable implant. The absorbable implant consists of a single monofilament that holds two sets of 8 cones. Both the monofilament and the cones are made from 82:18 L-lactide/ Glycolide bioresorbable (PURAC LG 8218) resin material.9517347701quality@sinclairpharma.com
05060033040133Silhouette Instalift - The Silhouette Instalift device consists of two 304 Stainless Steel Surgical needles and an absorbable implant. The absorbable implant consists of a single monofilament that holds two sets of 12 cones. Both the monofilament and the cones are made from 82:18 L-lactide/ Glycolide bioresorbable (PURAC LG 8218) resin material.9517347701quality@sinclairpharma.com
05060033040157Silhouette Instalift - The Silhouette Instalift device consists of two 304 Stainless Steel Surgical needles and an absorbable implant. The absorbable implant consists of a single monofilament that holds two sets of 16 cones. Both the monofilament and the cones are made from 82:18 L-lactide/ Glycolide bioresorbable (PURAC LG 8218) resin material.9517347701quality@sinclairpharma.com
05060033040171Silhouette Lift - Silhouette Lift suture is a non-absorbable polypropylene suture with an implantable grade L-lactide/Glycolide (PLG-8218) resorbable based cone that has been injection molded to strict tolerances and affixed to the polypropylene base suture in a secondary operation without any modification or degradation to the base suture. This model number of Silhouette Lift suture is 40.5 cm in length, with a total of 6 molded cones fixed to the distal end of the suture. Silhouette Lift suture is indicated for use in mid-face suspension surgery to fixate the cheek dermis in an elevated position.9517347701quality@sinclairpharma.com
05060033040195Silhouette Lift - Silhouette Lift suture is a non-absorbable polypropylene suture with an implantable grade L-lactide/Glycolide (PLG-8218) resorbable based cone that has been injection molded to strict tolerances and affixed to the polypropylene base suture in a secondary operation without any modification or degradation to the base suture. This model number of Silhouette Lift suture is 37.3 cm in length, with a total of 10 molded cones fixed to the distal end of the suture. Silhouette Lift suture is indicated for use in mid-face suspension surgery to fixate the cheek dermis in an elevated position.9517347701quality@sinclairpharma.com
05060033040218Silhouette Lift - Silhouette Lift suture is a non-absorbable polypropylene suture with an implantable grade L-lactide/Glycolide (PLG-8218) resorbable based cone that has been injection molded to strict tolerances and affixed to the polypropylene base suture in a secondary operation without any modification or degradation to the base suture. This model number of Silhouette Lift suture is 40.5 cm in length, with a total of 6 molded cones fixed to the distal end of the suture. Silhouette Lift suture is indicated for use in mid-face suspension surgery to fixate the cheek dermis in an elevated position.9517347701quality@sinclairpharma.com
05060033040232Silhouette Lift - Silhouette Lift suture is a non-absorbable polypropylene suture with an implantable grade L-lactide/Glycolide (PLG-8218) resorbable based cone that has been injection molded to strict tolerances and affixed to the polypropylene base suture in a secondary operation without any modification or degradation to the base suture. This model number of Silhouette Lift suture is 40.5 cm in length, with a total of 6 molded cones fixed to the distal end of the suture along with a blunt needle. Silhouette Lift suture is indicated for use in mid-face suspension surgery to fixate the cheek dermis in an elevated position.9517347701quality@sinclairpharma.com
05060033043028Silhouette Instalift - The Silhouette Instalift device consists of two 304 Stainless Steel Surgical needles and an absorbable implant. The absorbable implant consists of a single monofilament that holds two sets of 12 cones. Both the monofilament and the cones are made from 82:18 L-lactide / Glycolide bioresorbable (PURAC LG 8218) resin material.9517347701safety@sinclair.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1159921660304833K200140Silhouette InstaliftGAM2020-03-27
1159922027942669K191299Silhouette Featherlift / Silhouette LiftGAW2019-06-14
1159922061344654K163676Silhouette InstaLiftGAM2017-06-16
1159921275775016K142061SILHOUETTE INSTALIFTGAM2015-04-24
1159921799753060

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GAM32020-03-27
GAW12019-06-14

GUDID#

Silhouette Lift - Silhouette Lift suture is a non-absorbable polypropylene suture with an implantable grade L-lactide/Glycolide (PLG-8218) resorbable based cone that has been injection molded to strict tolerances and affixed to the polypropylene base suture in a secondary operation without any modification or degradation to the base suture. This model number of Silhouette Lift suture is 40.5 cm in length, with a total of 6 molded cones fixed to the distal end of the suture. Silhouette Lift suture is indicated for use in mid-face suspension surgery to fixate the cheek dermis in an elevated position.

Sinclair Pharma US Inc.

2015-09-24

Silhouette Lift - Silhouette Lift suture is a non-absorbable polypropylene suture with an implantable grade L-lactide/Glycolide (PLG-8218) resorbable based cone that has been injection molded to strict tolerances and affixed to the polypropylene base suture in a secondary operation without any modification or degradation to the base suture. This model number of Silhouette Lift suture is 37.3 cm in length, with a total of 10 molded cones fixed to the distal end of the suture. Silhouette Lift suture is indicated for use in mid-face suspension surgery to fixate the cheek dermis in an elevated position.

Sinclair Pharma US Inc.

2015-09-24

Silhouette Lift - Silhouette Lift suture is a non-absorbable polypropylene suture with an implantable grade L-lactide/Glycolide (PLG-8218) resorbable based cone that has been injection molded to strict tolerances and affixed to the polypropylene base suture in a secondary operation without any modification or degradation to the base suture. This model number of Silhouette Lift suture is 40.5 cm in length, with a total of 6 molded cones fixed to the distal end of the suture along with a blunt needle. Silhouette Lift suture is indicated for use in mid-face suspension surgery to fixate the cheek dermis in an elevated position.

Sinclair Pharma US Inc.

2015-09-24

Silhouette Lift - Silhouette Lift suture is a non-absorbable polypropylene suture with an implantable grade L-lactide/Glycolide (PLG-8218) resorbable based cone that has been injection molded to strict tolerances and affixed to the polypropylene base suture in a secondary operation without any modification or degradation to the base suture. This model number of Silhouette Lift suture is 40.5 cm in length, with a total of 6 molded cones fixed to the distal end of the suture. Silhouette Lift suture is indicated for use in mid-face suspension surgery to fixate the cheek dermis in an elevated position.

Sinclair Pharma US Inc.

2015-09-24