Hex Cortical Screw 4.0mm HEX4.0-55

GUDID 00842188107139

Hex Cortical Screw 4.0, 55mm

TRIMED, INCORPORATED

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00842188107139
• NIH Device Record Key: e2a041c2-714f-4e84-b1ea-f5a0a80e56c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hex Cortical Screw 4.0mm
• Version Model Number: HEX4.0-55
• Catalog Number: HEX4.0-55
• 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
• Phone: +1(661)255-7406
• Email: info@trimedortho.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842188107139 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060041

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

[00842188107139]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-07

On-Brand Devices [Hex Cortical Screw 4.0mm]

• 00842188107146: Hex Cortical Screw 4.0, 60mm
• 00842188107139: Hex Cortical Screw 4.0, 55mm
• 00842188107122: Hex Cortical Screw 4.0, 50mm
• 00842188107115: Hex Cortical Screw 4.0, 45mm
• 00842188107108: Hex Cortical Screw 4.0, 40mm
• 00842188107092: Hex Cortical Screw 4.0, 35mm