CHARLOTTE

GUDID 00840420102867

WRIGHT MEDICAL TECHNOLOGY, INC.

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00840420102867
• NIH Device Record Key: 7161f210-bdb3-4d9e-9098-cbe2396bad1e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CHARLOTTE
• Version Model Number: 43503746
• 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

Device Dimensions

• Outer Diameter: 3.7 Millimeter
• Length: 46 Millimeter
• Outer Diameter: 3.7 Millimeter
• Length: 46 Millimeter
• Outer Diameter: 3.7 Millimeter
• Length: 46 Millimeter
• Outer Diameter: 3.7 Millimeter
• Length: 46 Millimeter
• Outer Diameter: 3.7 Millimeter
• Length: 46 Millimeter
• Outer Diameter: 3.7 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840420102867 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081374

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[00840420102867]

Moist Heat or Steam Sterilization

[00840420102867]

Moist Heat or Steam Sterilization

[00840420102867]

Moist Heat or Steam Sterilization

[00840420102867]

Moist Heat or Steam Sterilization

[00840420102867]

Moist Heat or Steam Sterilization

[00840420102867]

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: 2015-10-01

On-Brand Devices [CHARLOTTE]

• 00889797012294: 43510145
• 00889797012287: 43510137
• 00889797012270: 43510132
• 00889797012263: 43510126
• 00889797012256: 43510125
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• 00889797010924: 41112001
• 00840420191991: 42112005
• 00840420191786: 44180030
• 00840420191045: 43112030
• 00840420190581: 43112001
• 00840420109644: 56016570
• 00840420109637: 56016565
• 00840420109620: 56016560
• 00840420109613: 56016555
• 00840420109606: 56016550
• 00840420109590: 56016545
• 00840420109583: 56016540
• 00840420109576: 56015570
• 00840420109569: 56015565
• 00840420109552: 56015560
• 00840420109545: 56015555
• 00840420109538: 56015550
• 00840420109521: 56015545
• 00840420109514: 56015540
• 00840420109507: 56014570
• 00840420109491: 56014565
• 00840420109484: 56014560
• 00840420109477: 56014555
• 00840420109460: 56014550
• 00840420109453: 56014545
• 00840420109446: 56014540
• 00840420109439: 45112714
• 00840420109422: 45112712
• 00840420109415: 45112711
• 00840420109408: 45112015
• 00840420109392: 45112013
• 00840420109385: 45110006
• 00840420109378: 45110005
• 00840420109361: 45110004
• 00840420109354: 45110003
• 00840420109347: 45110002
• 00840420109330: 45110001
• 00840420109323: 44187001
• 00840420109316: 44187000
• 00840420109309: 44179532
• 00840420109293: 44179516
• 00840420109286: 44179032