OIC Variable Angle Small Fragment Locking Plate Sy

GUDID 20811998034113

K-WIRE (10/PACK) 1.25MM X 150MM

ORTHOPAEDIC IMPLANT COMPANY, THE

Orthopaedic bone wire

• Primary Device ID: 20811998034113
• NIH Device Record Key: 68fd8491-8f47-443f-8f35-ae0fb68aafc0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OIC Variable Angle Small Fragment Locking Plate Sy
• Version Model Number: KW125-150
• Company DUNS: 070061160
• Company Name: ORTHOPAEDIC IMPLANT COMPANY, THE
• Device Count: 10
• 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: false
• 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: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com

Device Dimensions

• Length: 150 Millimeter
• Outer Diameter: 1.25 Millimeter
• Length: 150 Millimeter
• Outer Diameter: 1.25 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10811998034116 [Unit of Use]
GS1	20811998034113 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140357

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[20811998034113]

Moist Heat or Steam Sterilization

[20811998034113]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-08-31
• Device Publish Date: 2018-07-31

On-Brand Devices [OIC Variable Angle Small Fragment Locking Plate Sy]

• 20811998034137: K-WIRE (10/PACK) 2.0MM X 150MM
• 20811998034120: K-WIRE (10/PACK) 1.6MM X 150MM
• 20811998034113: K-WIRE (10/PACK) 1.25MM X 150MM