OIC IM NAIL SYSTEM

GUDID 20811998036599

CALIBRATED GUIDE PIN 3.2MM X 400MM

ORTHOPAEDIC IMPLANT COMPANY, THE

Orthopaedic bone wire

• Primary Device ID: 20811998036599
• NIH Device Record Key: 7353fda8-5bcf-42b3-8aca-b4dc16d2ed8c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OIC IM NAIL SYSTEM
• Version Model Number: 32-400P
• Company DUNS: 070061160
• Company Name: ORTHOPAEDIC IMPLANT COMPANY, THE
• Device Count: 5
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	10811998036592 [Unit of Use]
GS1	20811998036599 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150655

FDA Product Code

• HSB: Rod, Fixation, Intramedullary And Accessories

Sterilization

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

[20811998036599]

Moist Heat or Steam Sterilization

[20811998036599]

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 IM NAIL SYSTEM]

• 20811998036599: CALIBRATED GUIDE PIN 3.2MM X 400MM
• 10811998036592: 3.2 mm X 400 mm CALIBRATED GUIDEPIN (SINGLE UNIT)