AccessGUDID - DEVICE: Silhouette Instalift (05060033040157)

GUDID

Device Identifier (DI) Information

Brand Name: Silhouette Instalift
Version or Model: SMS 30-PLG-3.0.1-NA
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Sinclair Pharma US Inc.

Primary DI Number: 05060033040157
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 017003388 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
46859	Lift thread, bioabsorbable	A sterile filament made of a bioabsorbable material [e.g., poly-L-lactide (PLLA), poly(lactic-co-glycolic acid) (PLGA)] with projections (e.g., barbs or cones) 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 dedicated disposable implantation tools (e.g., needle, cannula).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K142061	000
K163676	000
K200140	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 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 53739cdb-1343-4047-a81d-571d625814fc
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
05060033040164	5	05060033040157	2018-07-12	Not in Commercial Distribution	Dispenser Box
05060033041741	5	05060033040157		In Commercial Distribution	Dispenser box