DEVICE: Silhouette Lift (05060033040195)

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Device Identifier (DI) Information

Silhouette Lift
SMS 02-PP-2.0.1-B

SILHOUETTE LIFT, INC.
05060033040195
GS1
2
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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).
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FDA Product Code

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

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 0 and 27 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 24, 2015

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
5060033040201 10 05060033040195 In Commercial Distribution Dispenser Box
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: 05060033040294 CLOSE

Direct Marking (DM)

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Yes
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
9517347701
quality@sinclairpharma.com
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