3.5 Cortical Screw TRXC3.5-28 T

GUDID 00842188120268

Cortical Screw 3.5, 28mm, T15, Ti

TRIMED, INCORPORATED

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00842188120268
• NIH Device Record Key: ba582d59-a557-4f8a-983a-aa76c97736d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3.5 Cortical Screw
• Version Model Number: TRXC3.5-28 T
• Catalog Number: TRXC3.5-28 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	00842188120268 [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

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

Moist Heat or Steam Sterilization

[00842188120268]

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 [3.5 Cortical Screw]

• 00842188118890: Cortical Screw 3.5, 60mm, Hex 2.5, Ti
• 00842188118883: Cortical Screw 3.5, 55mm, Hex 2.5, Ti
• 00842188118876: Cortical Screw 3.5, 50mm, Hex 2.5, Ti
• 00842188118869: Cortical Screw 3.5, 48mm, Hex 2.5, Ti
• 00842188118852: Cortical Screw 3.5, 46mm, Hex 2.5, Ti
• 00842188118845: Cortical Screw 3.5, 44mm, Hex 2.5, Ti
• 00842188118838: Cortical Screw 3.5, 42mm, Hex 2.5, Ti
• 00842188118821: Cortical Screw 3.5, 40mm, Hex 2.5, Ti
• 00842188118814: Cortical Screw 3.5, 38mm, Hex 2.5, Ti
• 00842188118807: Cortical Screw 3.5, 36mm, Hex 2.5, Ti
• 00842188118791: Cortical Screw 3.5, 34mm, Hex 2.5, Ti
• 00842188118784: Cortical Screw 3.5, 32mm, Hex 2.5, Ti
• 00842188118777: Cortical Screw 3.5, 30mm, Hex 2.5, Ti
• 00842188118760: Cortical Screw 3.5, 28mm, Hex 2.5, Ti
• 00842188118753: Cortical Screw 3.5, 26mm, Hex 2.5, Ti
• 00842188118746: Cortical Screw 3.5, 24mm, Hex 2.5, Ti
• 00842188118739: Cortical Screw 3.5, 22mm, Hex 2.5, Ti
• 00842188118722: Cortical Screw 3.5, 20mm, Hex 2.5, Ti
• 00842188118715: Cortical Screw 3.5, 18mm, Hex 2.5, Ti
• 00842188118708: Cortical Screw 3.5, 16mm, Hex 2.5, Ti
• 00842188118692: Cortical Screw 3.5, 14mm, Hex 2.5, Ti
• 00842188118685: Cortical Screw 3.5, 12mm, Hex 2.5, Ti
• 00842188118678: Cortical Screw 3.5, 10mm, Hex 2.5, Ti
• 00842188118661: Cortical Screw 3.5, 08mm, Hex 2.5, Ti
• 00842188120398: Cortical Screw 3.5, 60mm, T15, Ti
• 00842188120381: Cortical Screw 3.5, 55mm, T15, Ti
• 00842188120374: Cortical Screw 3.5, 50mm, T15, Ti
• 00842188120367: Cortical Screw 3.5, 48mm, T15, Ti
• 00842188120350: Cortical Screw 3.5, 46mm, T15, Ti
• 00842188120343: Cortical Screw 3.5, 44mm, T15, Ti
• 00842188120336: Cortical Screw 3.5, 42mm, T15, Ti
• 00842188120329: Cortical Screw 3.5, 40mm, T15, Ti
• 00842188120312: Cortical Screw 3.5, 38mm, T15, Ti
• 00842188120305: Cortical Screw 3.5, 36mm, T15, Ti
• 00842188120299: Cortical Screw 3.5, 34mm, T15, Ti
• 00842188120282: Cortical Screw 3.5, 32mm, T15, Ti
• 00842188120275: Cortical Screw 3.5, 30mm, T15, Ti
• 00842188120268: Cortical Screw 3.5, 28mm, T15, Ti
• 00842188120251: Cortical Screw 3.5, 26mm, T15, Ti
• 00842188120244: Cortical Screw 3.5, 24mm, T15, Ti
• 00842188120237: Cortical Screw 3.5, 22mm, T15, Ti
• 00842188120220: Cortical Screw 3.5, 20mm, T15, Ti
• 00842188120213: Cortical Screw 3.5, 18mm, T15, Ti
• 00842188120206: Cortical Screw 3.5, 16mm, T15, Ti
• 00842188120190: Cortical Screw 3.5, 14mm, T15, Ti
• 00842188120183: Cortical Screw 3.5, 12mm, T15, Ti
• 00842188120176: Cortical Screw 3.5, 10mm, T15, Ti
• 00842188120169: Cortical Screw 3.5, 08mm, T15, Ti