CannCompScrew 4.5mm (SelfDrill) S4538

GUDID 00842188103476

Self-Drill CCScrew SThd 4.5, 38mm

TRIMED, INCORPORATED

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00842188103476
• NIH Device Record Key: 8744bc16-320c-4c87-b658-97c0d52dd947
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CannCompScrew 4.5mm (SelfDrill)
• Version Model Number: S4538
• Catalog Number: S4538
• 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	00842188103476 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093676

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

Moist Heat or Steam Sterilization

[00842188103476]

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 [CannCompScrew 4.5mm (SelfDrill)]

• 00842188103551: Self-Drill CCScrew SThd 4.5, 64mm
• 00842188103544: Self-Drill CCScrew SThd 4.5, 60mm
• 00842188103537: Self-Drill CCScrew SThd 4.5, 56mm
• 00842188103520: Self-Drill CCScrew SThd 4.5, 52mm
• 00842188103513: Self-Drill CCScrew SThd 4.5, 48mm
• 00842188103506: Self-Drill CCScrew SThd 4.5, 44mm
• 00842188103490: Self-Drill CCScrew SThd 4.5, 42mm
• 00842188103483: Self-Drill CCScrew SThd 4.5, 40mm
• 00842188103476: Self-Drill CCScrew SThd 4.5, 38mm
• 00842188103469: Self-Drill CCScrew SThd 4.5, 36mm
• 00842188103452: Self-Drill CCScrew SThd 4.5, 34mm
• 00842188103445: Self-Drill CCScrew SThd 4.5, 32mm
• 00842188103438: Self-Drill CCScrew SThd 4.5, 30mm
• 00842188103421: Self-Drill CCScrew SThd 4.5, 28mm
• 00842188103414: Self-Drill CCScrew SThd 4.5, 26mm
• 00842188122392: Self-Drill CCScrew LThd 4.5, 64mm
• 00842188122385: Self-Drill CCScrew LThd 4.5, 60mm
• 00842188122378: Self-Drill CCScrew LThd 4.5, 56mm
• 00842188122361: Self-Drill CCScrew LThd 4.5, 52mm
• 00842188122354: Self-Drill CCScrew LThd 4.5, 48mm
• 00842188122347: Self-Drill CCScrew LThd 4.5, 44mm
• 00842188122330: Self-Drill CCScrew LThd 4.5, 42mm
• 00842188122323: Self-Drill CCScrew LThd 4.5, 44mm