AccessGUDID - DEVICE: Silhouette Lift (05060033040171)

GUDID

Device Identifier (DI) Information

Brand Name: Silhouette Lift
Version or Model: SMS 01-PP-3.0.1-B-S
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Sinclair Pharma US Inc.

Primary DI Number: 05060033040171
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 017003388 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46860	Lift thread, partially-bioabsorbable	A 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).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K060414	000
K171005	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 0 and 27 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2bf1be51-2086-475b-aa48-99eefbd187f4
Public Version Date: May 23, 2022
Public Version Number: 7
DI Record Publish Date: September 24, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
5060033040188	10	05060033040171	2018-05-30	Not in Commercial Distribution	Dispenser Box
05060033040188	10	05060033040171	2018-05-30	Not in Commercial Distribution	Dispenser box
05060033041987	10	05060033040171		In Commercial Distribution	Dispener Box