4.0 Cortical Screw TRXC4.0-38 T

GUDID 00842188120558

Cortical Screw 4.0, 38mm, T15, Ti

TRIMED, INCORPORATED

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00842188120558
• NIH Device Record Key: 92d983cd-c289-41de-8385-7e0bba00baa5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 4.0 Cortical Screw
• Version Model Number: TRXC4.0-38 T
• Catalog Number: TRXC4.0-38 T
• Company DUNS: 138041277
• Company Name: TRIMED, INCORPORATED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
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Device Identifiers

Device Issuing Agency	Device ID
GS1	00842188120558 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192696

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

[00842188120558]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-28
• Device Publish Date: 2020-01-20

On-Brand Devices [4.0 Cortical Screw]

• 00842188120633: Cortical Screw 4.0, 60mm, T15, Ti
• 00842188120626: Cortical Screw 4.0, 55mm, T15, Ti
• 00842188120619: Cortical Screw 4.0, 50mm, T15, Ti
• 00842188120602: Cortical Screw 4.0, 48mm, T15, Ti
• 00842188120596: Cortical Screw 4.0, 46mm, T15, Ti
• 00842188120589: Cortical Screw 4.0, 44mm, T15, Ti
• 00842188120572: Cortical Screw 4.0, 42mm, T15, Ti
• 00842188120565: Cortical Screw 4.0, 40mm, T15, Ti
• 00842188120558: Cortical Screw 4.0, 38mm, T15, Ti
• 00842188120541: Cortical Screw 4.0, 36mm, T15, Ti
• 00842188120534: Cortical Screw 4.0, 34mm, T15, Ti
• 00842188120527: Cortical Screw 4.0, 32mm, T15, Ti
• 00842188120510: Cortical Screw 4.0, 30mm, T15, Ti
• 00842188120503: Cortical Screw 4.0, 28mm, T15, Ti
• 00842188120497: Cortical Screw 4.0, 26mm, T15, Ti
• 00842188120480: Cortical Screw 4.0, 24mm, T15, Ti
• 00842188120473: Cortical Screw 4.0, 22mm, T15, Ti
• 00842188120466: Cortical Screw 4.0, 20mm, T15, Ti
• 00842188120459: Cortical Screw 4.0, 18mm, T15, Ti
• 00842188120442: Cortical Screw 4.0, 16mm, T15, Ti
• 00842188120435: Cortical Screw 4.0, 14mm, T15, Ti
• 00842188120428: Cortical Screw 4.0, 12mm, T15, Ti
• 00842188120411: Cortical Screw 4.0, 10mm, T15, Ti
• 00842188120404: Cortical Screw 4.0, 08mm, T15, Ti