TCP

GUDID 00840420118714

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

• Primary Device ID: 00840420118714
• NIH Device Record Key: 920ca124-2efa-4d71-917b-7e84b13fb8f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TCP
• Version Model Number: 03-9005-34
• 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

Device Dimensions

• Outer Diameter: 2.7 Millimeter
• Length: 34 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 34 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 34 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 34 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 34 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 34 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 34 Millimeter
• Outer Diameter: 2.7 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840420118714 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K094037

FDA Product Code

• HRS: PLATE, FIXATION, BONE

Sterilization

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

[00840420118714]

Moist Heat or Steam Sterilization

[00840420118714]

Moist Heat or Steam Sterilization

[00840420118714]

Moist Heat or Steam Sterilization

[00840420118714]

Moist Heat or Steam Sterilization

[00840420118714]

Moist Heat or Steam Sterilization

[00840420118714]

Moist Heat or Steam Sterilization

[00840420118714]

Moist Heat or Steam Sterilization

[00840420118714]

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 [TCP]

• 00889797038461: 08-705
• 00889797038454: 08-704
• 00889797038447: 08-703
• 00889797038430: 08-702
• 00889797038348: 08-613
• 00889797038294: 08-602
• 00840420118929: 03-9006-24
• 00840420118912: 03-9004-10
• 00840420118905: 03-9010-10
• 00840420118882: 07-308
• 00840420118875: 07-322
• 00840420118868: 03-9006-10
• 00840420118844: 03-9004-32
• 00840420118837: 03-9004-36
• 00840420118820: 07-750
• 00840420118813: 03-9005-26
• 00840420118806: 07-745
• 00840420118790: 03-9010-32
• 00840420118783: 03-9005-28
• 00840420118776: 03-9010-50
• 00840420118769: 03-9010-40
• 00840420118752: 03-9010-42
• 00840420118745: 03-9010-46
• 00840420118738: 03-9010-44
• 00840420118721: 03-9006-34
• 00840420118714: 03-9005-34
• 00840420118707: 03-9010-48
• 00840420118691: 03-9006-32
• 00840420118684: 03-9006-36
• 00840420118677: 03-9005-32
• 00840420118660: 03-9006-38
• 00840420118653: 03-9005-36
• 00840420118646: 03-9006-40
• 00840420118639: 03-9006-48
• 00840420118622: 03-9006-50
• 00840420118615: 03-9006-42
• 00840420118608: 03-9006-46
• 00840420118592: 03-9006-44
• 00840420118585: 07-528
• 00840420118578: 07-526
• 00840420118561: 07-735
• 00840420118554: 03-9013-8
• 00840420118547: 03-9013-16
• 00840420118530: 03-9010-34
• 00840420118523: 07-208
• 00840420118516: 03-9004-12
• 00840420118509: 03-9010-30
• 00840420118493: 03-9004-34
• 00840420118486: 03-9010-36
• 00840420118479: 07-120