Distal Radius E-Kit

GUDID 00840118111249

surgical instrument or accessory for orthopedic bone fixation, includes 2 screwdrivers, hook tip probe, and K-wires (1.4mm)

FLOWER ORTHOPEDICS CORPORATION

Orthopaedic bone wire

• Primary Device ID: 00840118111249
• NIH Device Record Key: f624ebf4-d84f-4692-80cd-6e96cd35b8ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Distal Radius E-Kit
• Version Model Number: KWK 901
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00840118111249 [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

Devices Manufactured by FLOWER ORTHOPEDICS CORPORATION

• 00840118124133 - Flower Orthopedics: 2024-12-25 OsteoCoil Nitinol Compression System- 4.5mm x 55mm
• 00840118124461 - Flower Orthopedics: 2024-12-25 OsteoCoil Nitinol Compression System- 6.5mm x 70mm
• 00840118124508 - Flower Orthopedics: 2024-12-25 OsteoCoil Nitinol Compression System- 6.5mm x 90mm
• 00840118124683 - Flower Orthopedics: 2024-12-25 OsteoCoil Nitinol Compression System- 7.3mm x 55mm
• 00840118124768 - Flower Orthopedics: 2024-12-25 OsteoCoil Nitinol Compression System- 7.3mm x 95mm
• 00840118124836 - Flower Orthopedics: 2024-12-25 OsteoCoil Nitinol Compression System- 7.3mm x 130mm
• 00840118124102 - Flower Orthopedics: 2024-12-12 OsteoCoil Nitinol Compression System- 4.5mm x 40mm
• 00840118124119 - Flower Orthopedics: 2024-12-12 OsteoCoil Nitinol Compression System- 4.5mm x 45mm