EZ FRAME

GUDID 00889797058582

WRIGHT MEDICAL TECHNOLOGY, INC.

External orthopaedic fixation system, single-use

• Primary Device ID: 00889797058582
• NIH Device Record Key: ec72df61-36d7-4d85-9783-65d7bf305774
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EZ FRAME
• Version Model Number: EF3010PK
• 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
• 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
• 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
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com

Device Dimensions

• Height: 10 Millimeter
• Height: 10 Millimeter
• Height: 10 Millimeter
• Height: 10 Millimeter
• Height: 10 Millimeter
• Height: 10 Millimeter
• Height: 10 Millimeter
• Height: 10 Millimeter
• Height: 10 Millimeter
• Height: 10 Millimeter
• Height: 10 Millimeter
• Height: 10 Millimeter
• Height: 10 Millimeter
• Height: 10 Millimeter
• Height: 10 Millimeter
• Height: 10 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889797058582 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143220

FDA Product Code

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

Sterilization

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

[00889797058582]

Moist Heat or Steam Sterilization

[00889797058582]

Moist Heat or Steam Sterilization

[00889797058582]

Moist Heat or Steam Sterilization

[00889797058582]

Moist Heat or Steam Sterilization

[00889797058582]

Moist Heat or Steam Sterilization

[00889797058582]

Moist Heat or Steam Sterilization

[00889797058582]

Moist Heat or Steam Sterilization

[00889797058582]

Moist Heat or Steam Sterilization

[00889797058582]

Moist Heat or Steam Sterilization

[00889797058582]

Moist Heat or Steam Sterilization

[00889797058582]

Moist Heat or Steam Sterilization

[00889797058582]

Moist Heat or Steam Sterilization

[00889797058582]

Moist Heat or Steam Sterilization

[00889797058582]

Moist Heat or Steam Sterilization

[00889797058582]

Moist Heat or Steam Sterilization

[00889797058582]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-11-23
• Device Publish Date: 2015-10-24

On-Brand Devices [EZ FRAME]

• 00889797058599: EF375000
• 00889797066723: EF002500
• 00889797066709: EF003775
• 00889797066693: EF003750
• 00889797058582: EF3010PK
• 00889797058575: EF3005PK
• 00889797058544: EF1650PK
• 00889797058513: EF003010
• 00889797058506: EF003005
• 00889797058490: EF002450
• 00889797058476: EF002000
• 00889797058469: EF001650
• 00889797058414: EF410160
• 00889797058360: EF190002
• 00889797058322: EF004180
• 00889797058315: EF002550
• 00889797056014: EF10000L
• 00889797056618: EF103775
• 00889797056601: EF103750
• 00889797056007: EF100000