BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SINCLAIR PHARMA US, INC.

    Reg #: 3007009755 · FEI: 3007009755 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    4
    Classifications
    1

    Registration Details

    Registration Name
    SINCLAIR PHARMA US, INC.
    Registration Number
    3007009755
    FEI Number
    3007009755
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    18 TECHNOLOGY DRIVE, SUITE 134
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US

    Regulatory Submissions

    510(k) Number
    K142061

    Owner / Operator

    Firm Name
    SINCLAIR PHARMA US, INC.
    Operator Number
    10032162
    Address
    18 Technology Drive, STE 134
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US
    Correspondent
    Anthony DiBernardo

    Products

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

    Proprietary Names

    Silhouette Instalift Silhouette Soft Suture, SMS 25 (5 x SMS 25-PL-3.1-NA) Silhouette Soft Suture, SMS 100 (2 x SMS 22-PL-3.1-NA + 1 x SMS 23-PL-3.1-NA) Silhouette Soft Suture, SMS 22 (5 x SMS 22-PL-3.1-NA) Silhouette Soft Suture, SMS 23 (5 x SMS 23-PL-3.1-NA) Silhouette Soft Suture, SMS 102 (3 x SMS 22-PL-3.1-NA) Silhouette Soft Suture, SMS 26 (5 x SMS 26-PL-3.1-NA)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Manufacture Device in the United States for Export Only