EVOLVE

GUDID 00840420126047

WRIGHT MEDICAL TECHNOLOGY, INC.

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• Primary Device ID: 00840420126047
• NIH Device Record Key: ed2c5579-d9e9-4fcd-aba6-1a8dad8b134b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVOLVE
• Version Model Number: 496H018
• 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: true
• 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

Device Dimensions

• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840420126047 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060731

FDA Product Code

• KWI: PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-01

On-Brand Devices [EVOLVE]

• 00889797016681: 49510042
• 00889797016650: 49510039
• 00889797016445: 49510014
• 00889797016438: 49510013
• 00889797001168: 24900040
• 00840420117205: 4983532N
• 00840420117199: 4973510N
• 00840420117083: 4973538N
• 00840420117069: 4983538N
• 00840420117052: 4983534N
• 00840420117014: 4972732N
• 00840420117007: 4983536N
• 00840420116994: 4983528N
• 00840420116949: 4983526N
• 00840420116932: 4972710N
• 00840420116925: 4983510N
• 00840420116918: 4973555N
• 00840420116895: 4983555N
• 00840420116888: 4972740N
• 00840420116871: 4983512N
• 00840420116864: 4983514N
• 00840420116840: 4983560N
• 00840420116826: 4972738N
• 00840420116802: 4983530N
• 00840420116796: 4973540N
• 00840420116789: 4983550N
• 00840420116765: 4973560N
• 00840420116734: 4983545N
• 00840420116727: 4973545N
• 00840420116703: 4983524N
• 00840420116697: 4983518N
• 00840420116680: 4983540N
• 00840420116666: 4973534N
• 00840420116635: 4973550N
• 00840420116611: 4972745N
• 00840420116604: 4972736N
• 00840420116574: 4972734N
• 00840420116567: 4983522N
• 00840420116550: 4973512N
• 00840420116536: 4983520N
• 00840420116529: 4973536N
• 00840420116468: 4972730N
• 00840420116444: 4972728N
• 00840420116437: 4973532N
• 00840420116420: 4972712N
• 00840420116390: 4983516N
• 00840420116369: 4972726N
• 00840420116352: 4972750N
• 00840420116338: 4973530N
• 00840420116321: 4972714N