Clavicle Plates CPSLATR-11

GUDID 00842188100406

Superior Lateral Plate, Rt, 11-Hole

TRIMED, INCORPORATED

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: 00842188100406
• NIH Device Record Key: 34abc59e-edc4-4ae9-bbfa-87017b28cecc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clavicle Plates
• Version Model Number: CPSLATR-11
• Catalog Number: CPSLATR-11
• 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
• 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	00842188100406 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112509

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

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

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

Moist Heat or Steam Sterilization

[00842188100406]

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 [Clavicle Plates]

• 00842188100420: Superior Lateral Plate, Rt, 15-Hole
• 00842188100413: Superior Lateral Plate, Rt, 12-Hole
• 00842188100406: Superior Lateral Plate, Rt, 11-Hole
• 00842188100390: Superior Lateral Plate, Rt, 9-Hole
• 00842188100383: Superior Midshaft Plate, Rt, 10-Hole
• 00842188100376: Superior Midshaft Plate, Rt, 9-Hole
• 00842188100369: Superior Midshaft Plate, Rt, 8-Hole
• 00842188100352: Superior Midshaft Plate, Rt, 7-Hole
• 00842188100345: Superior Lateral Plate, Lt, 15-Hole
• 00842188100338: Superior Lateral Plate, Lt, 12-Hole
• 00842188100321: Superior Lateral Plate, Lt, 11-Hole
• 00842188100314: Superior Latera Plate, Lt, 9-Hole
• 00842188100307: Superior Midshaft Plate, Lt, 10-Hole
• 00842188100291: Superior Midshaft Plate, Lt, 9-Hole
• 00842188100284: Superior Midshaft Plate, Lt, 8-Hole
• 00842188100277: Superior Midshaft Plate, Lt, 7-Hole
• 00842188100260: Anterior Midshaft Plate, 11-Hole
• 00842188100253: Anterior Midshaft Plate, 8-Hole
• 00842188100246: Anterior Lateral Plate, 8-Hole
• 00842188124884: Superior Mediolateral Plate, Rt, 8-Hole
• 00842188124877: Superior Mediolateral Plate, Lt, 8-Hole