DART-FIRE

GUDID 00840420120335

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 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 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-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding)

• Primary Device ID: 00840420120335
• NIH Device Record Key: 8dde6911-88c2-495c-8675-aef40949db04
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DART-FIRE
• Version Model Number: D1N20012S
• 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
• 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
• 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
• 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

• Outer Diameter: 2 Millimeter
• Length: 12 Millimeter
• Device Size Text, specify: 0
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Device Identifiers

Device Issuing Agency	Device ID
GS1	00840420120335 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082320

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[00840420120335]

Moist Heat or Steam Sterilization

[00840420120335]

Moist Heat or Steam Sterilization

[00840420120335]

Moist Heat or Steam Sterilization

[00840420120335]

Moist Heat or Steam Sterilization

[00840420120335]

Moist Heat or Steam Sterilization

[00840420120335]

Moist Heat or Steam Sterilization

[00840420120335]

Moist Heat or Steam Sterilization

[00840420120335]

Moist Heat or Steam Sterilization

[00840420120335]

Moist Heat or Steam Sterilization

[00840420120335]

Moist Heat or Steam Sterilization

[00840420120335]

Moist Heat or Steam Sterilization

[00840420120335]

Moist Heat or Steam Sterilization

[00840420120335]

Moist Heat or Steam Sterilization

[00840420120335]

Moist Heat or Steam Sterilization

[00840420120335]

Moist Heat or Steam Sterilization

[00840420120335]

Moist Heat or Steam Sterilization

[00840420120335]

Moist Heat or Steam Sterilization

[00840420120335]

Moist Heat or Steam Sterilization

[00840420120335]

Moist Heat or Steam Sterilization

[00840420120335]

Moist Heat or Steam Sterilization

[00840420120335]

Moist Heat or Steam Sterilization

[00840420120335]

Moist Heat or Steam Sterilization

[00840420120335]

Moist Heat or Steam Sterilization

[00840420120335]

Moist Heat or Steam Sterilization

[00840420120335]

Moist Heat or Steam Sterilization

[00840420120335]

Moist Heat or Steam Sterilization

[00840420120335]

Moist Heat or Steam Sterilization

[00840420120335]

Moist Heat or Steam Sterilization

[00840420120335]

Moist Heat or Steam Sterilization

[00840420120335]

Moist Heat or Steam Sterilization

[00840420120335]

Moist Heat or Steam Sterilization

[00840420120335]

Moist Heat or Steam Sterilization

[00840420120335]

Moist Heat or Steam Sterilization

[00840420120335]

Moist Heat or Steam Sterilization

[00840420120335]

Moist Heat or Steam Sterilization

[00840420120335]

Moist Heat or Steam Sterilization

[00840420120335]

Moist Heat or Steam Sterilization

[00840420120335]

Moist Heat or Steam Sterilization

[00840420120335]

Moist Heat or Steam Sterilization

[00840420120335]

Moist Heat or Steam Sterilization

[00840420120335]

Moist Heat or Steam Sterilization

[00840420120335]

Moist Heat or Steam Sterilization

[00840420120335]

Moist Heat or Steam Sterilization

[00840420120335]

Moist Heat or Steam Sterilization

[00840420120335]

Moist Heat or Steam Sterilization

[00840420120335]

Moist Heat or Steam Sterilization

[00840420120335]

Moist Heat or Steam Sterilization

[00840420120335]

Moist Heat or Steam Sterilization

[00840420120335]

Moist Heat or Steam Sterilization

[00840420120335]

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 [DART-FIRE]

• 00840420124517: 5881035001
• 00840420121486: D2N30008
• 00840420121479: D2N25040
• 00840420121462: D2N25038
• 00840420121455: D2N30010
• 00840420121448: D2N25034
• 00840420121431: D2N25032
• 00840420121424: D2N30012
• 00840420121417: D2N25028
• 00840420121400: D2N25030
• 00840420121394: D2N25010
• 00840420121387: D2N25026
• 00840420121370: D2N30036
• 00840420121363: D2N25036
• 00840420121356: D2N30038
• 00840420121349: D2N30034
• 00840420121332: D2N25024
• 00840420121325: D2N30032
• 00840420121318: D2N25022
• 00840420121301: D2N25012
• 00840420121295: D2N30028
• 00840420121288: D2N30026
• 00840420121271: D2N30014
• 00840420121264: D2N30040
• 00840420121257: D2N30022
• 00840420121240: D2N30030
• 00840420121233: D2N30020
• 00840420121226: D2N30024
• 00840420121219: D2N25018
• 00840420121202: D2N25020
• 00840420121196: D2N30016
• 00840420121189: D2N25014
• 00840420121172: D2N30018
• 00840420121165: D2N25016
• 00840420121158: D1N35058S
• 00840420121141: D1N35052S
• 00840420121134: D1N40010S
• 00840420121127: D1N35060S
• 00840420121110: D1N35056S
• 00840420121103: D1N40012S
• 00840420121097: D1N35010S
• 00840420121080: D1N40014S
• 00840420121073: D1N40016S
• 00840420121066: D1N35048S
• 00840420121059: D1N40018S
• 00840420121042: D1N35012S
• 00840420121035: D1N30010S
• 00840420121028: D1N25030S
• 00840420121011: D1N25034S
• 00840420121004: D1N35014S