K-Wires

GUDID 00840118110099

Qty. 2, surgical instrument or accessory for orthopedic bone fixation

FLOWER ORTHOPEDICS CORPORATION

Orthopaedic bone wire

• Primary Device ID: 00840118110099
• NIH Device Record Key: eae1c099-8672-42db-94fd-581c8258d307
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: K-Wires
• Version Model Number: KWK 101
• Company DUNS: 078790947
• Company Name: FLOWER ORTHOPEDICS CORPORATION
• 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: false
• 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: 8777788587
• Email: info@flowerortho.com
• Phone: 8777788587
• Email: info@flowerortho.com

Device Dimensions

• Outer Diameter: 0.8 Millimeter
• Length: 140 Millimeter
• Outer Diameter: 0.8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840118110099 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123562

FDA Product Code

• HTY: Pin, Fixation, Smooth

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: 2015-09-22

On-Brand Devices [K-Wires]

• 00840118110105: Qty 2, surgical instrument or accessory for orthopedic bone fixation
• 00840118110099: Qty. 2, surgical instrument or accessory for orthopedic bone fixation