EF002450

GUDID 00889797103077

WRIGHT MEDICAL TECHNOLOGY, INC.

External orthopaedic fixation system, single-use

• Primary Device ID: 00889797103077
• NIH Device Record Key: a643e281-5121-4eb3-90fa-9360b12ba494
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: EF002450
• Catalog Number: EF002450
• Company DUNS: 807201207
• Company Name: WRIGHT MEDICAL TECHNOLOGY, INC.
• 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: true
• 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(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889797103077 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130044

FDA Product Code

• KTT: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

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

[00889797103077]

Moist Heat or Steam Sterilization

[00889797103077]

Moist Heat or Steam Sterilization

[00889797103077]

Moist Heat or Steam Sterilization

[00889797103077]

Moist Heat or Steam Sterilization

[00889797103077]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-08
• Device Publish Date: 2022-05-31

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