BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Integra SZT-715-01S Lunate Sizing Template Sz. 01

    Reg #: 1649379 · FEI: 3000718490 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    55
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BANISTER TOOL, INC.
    Registration Number
    1649379
    FEI Number
    3000718490
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3009 A W Grimes Blvd
    City
    Pflugerville
    State
    TX
    ZIP
    78660
    Country
    US

    Owner / Operator

    Firm Name
    Banister Tool, Inc.
    Operator Number
    10042616
    Address
    3009 A W Grimes Blvd
    City
    Pflugerville
    State
    TX
    Postal Code
    78660
    Country
    US
    Correspondent
    Burke Ramsay

    Products

    Device Name Product Code
    Template HWT

    Proprietary Names

    Integra SZT-715-01S Lunate Sizing Template Sz. 01 Integra TMP-200-01 PIP Distal Template Integra OSG-910-03 PYC Titan Sizing Gage 3 Integra TMP-400-40 Sizing Template, PHS Sz. 40 Integra TRL-443-40L NuGrip Trial Sz. 40L Integra TRL-443-30L NuGrip Trial Sz. 30L Integra TRL-420-187 PYD Trial Sz. 187 Integra SZT-715-03S Lunate Sizing Template Sz. 03 Integra TRL-101-10D MCP Distal Metal Trial Sz. 10 Integra TRL-715-01T Lunate Trial Sz. 01 Integra TRL-101-20D MCP Distal Metal Trial Sz. 20 Integra SZT-715-04S Lunate Sizing Template Sz. 04 Integra TRL-443-20S NuGrip Trial Sz. 20S Integra TRL-101-20P MCP Proximal Metal Trial Sz. 20 Integra TRL-101-40P MCP Proximal Metal Trial Sz. 40 Integra TRL-101-50D MCP Distal Metal Trial Sz. 50 Integra SZT-715-02S Lunate Sizing Template Sz. 02 Integra TRL-202-10P PIP Proximal Ti Trial Sz. 10 Integra OSG-910-01 PYC Titan Sizing Gage 1 Integra TMP-400-30 Sizing Template, PHS Sz. 30 Integra TRL-443-20M NuGrip Trial Sz. 20M Integra TMP-400-10 Sizing Template, PHS Sz. 10 Integra TRL-420-168 PYD Trial Sz. 168 Integra TMP-400-50 Sizing Template, PHS Sz. 50 Integra TRL-202-40P PIP Proximal Ti Trial Sz. 40 Integra TRL-101-05D MCP Distal Metal Trial Sz. 05 Integra TRL-202-20P PIP Proximal Ti Trial Sz. 20 Integra TRL-101-30D MCP Distal Metal Trial Sz. 30 Integra TRL-101-10P MCP Proximal Metal Trial Sz. 10 Integra TRL-443-10M NuGrip Trial Sz. 10M Integra TRL-420-189 PYD Trial Sz. 189 Integra TRL-443-30S NuGrip Trial Sz. 30S Integra TRL-202-30D PIP Distal Ti Trial Sz. 30 Integra TRL-202-40D PIP Distal Ti Trial Sz. 40 Integra TRL-420-167 PYD Trial Sz. 167 Integra TRL-202-20D PIP Distal Ti Trial Sz. 20 Integra TRL-443-10S NuGrip Trial Sz. 10S Integra TRL-101-30P MCP Proximal Metal Trial Sz. 30 Integra TRL-443-40M NuGrip Trial Sz. 40M Integra TRL-715-02T Lunate Trial Sz. 02 RSS Definitive Stem Body Trial, Standard DWG-0960-020-502 RSS Glenosphere Trial, Eccentric-S DWG-04-0961-035-502 NuGrip Template Sz S DWG-04-443-004-S RSS Head Cutting Template 142.5A, Right DWG-04-0961-041-501 RSS Head Cutting Template 142.5A, Left DWG-04-0961-041-501 RSS Glenosphere Trial, Concentric-S DWG-04-0961-035-501 RSS Definitive Stem Body Trial, Large DWG-0960-020-502 MUH Stem Trial Sz 4.5 DWG-04-605-002 Sz 4.5 MUH Head Trial Sz 16 DWG-04-605-001 Sz 16 Humeral Body Trial, STD Mod DWG-0960-020-501 Humeral Body Trial, SML Mod DWG-0960-020-501 CMRH Head Trial Sz 22L DWG-04-315-001 Sz 22L RSS Definitive Stem Body Trial, Small DWG-0960-020-502 Humeral Body Trial, LRG Mod DWG-0960-020-501 ZS 3559-2 Targeting Incision Guide Template

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)