ART End Cap ART-13-C00

GUDID B058ART13C001

ART End Cap Ø13mm x 00mm (flush)

Orthopedic Designs North America, Inc.

Bone nail end-cap

• Primary Device ID: B058ART13C001
• NIH Device Record Key: 8bf1f5c4-c42f-4a02-a1e8-9eb92bf5252a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ART End Cap
• Version Model Number: ART13C00
• Catalog Number: ART-13-C00
• Company DUNS: 945518848
• Company Name: Orthopedic Designs North America, 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: 888-635-8535
• Email: support@odi-na.com
• Phone: 888-635-8535
• Email: support@odi-na.com
• Phone: 888-635-8535
• Email: support@odi-na.com
• Phone: 888-635-8535
• Email: support@odi-na.com
• Phone: 888-635-8535
• Email: support@odi-na.com
• Phone: 888-635-8535
• Email: support@odi-na.com
• Phone: 888-635-8535
• Email: support@odi-na.com
• Phone: 888-635-8535
• Email: support@odi-na.com
• Phone: 888-635-8535
• Email: support@odi-na.com
• Phone: 888-635-8535
• Email: support@odi-na.com
• Phone: 888-635-8535
• Email: support@odi-na.com
• Phone: 888-635-8535
• Email: support@odi-na.com
• Phone: 888-635-8535
• Email: support@odi-na.com
• Phone: 888-635-8535
• Email: support@odi-na.com
• Phone: 888-635-8535
• Email: support@odi-na.com
• Phone: 888-635-8535
• Email: support@odi-na.com

Device Dimensions

• Outer Diameter: 13 Millimeter
• Length: 0 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 0 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 0 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 0 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 0 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 0 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 0 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 0 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 0 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 0 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 0 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 0 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 0 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 0 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 0 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 0 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B058ART13C001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152295

FDA Product Code

• HSB: Rod, Fixation, Intramedullary And Accessories

Sterilization

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

[B058ART13C001]

Moist Heat or Steam Sterilization

[B058ART13C001]

Moist Heat or Steam Sterilization

[B058ART13C001]

Moist Heat or Steam Sterilization

[B058ART13C001]

Moist Heat or Steam Sterilization

[B058ART13C001]

Moist Heat or Steam Sterilization

[B058ART13C001]

Moist Heat or Steam Sterilization

[B058ART13C001]

Moist Heat or Steam Sterilization

[B058ART13C001]

Moist Heat or Steam Sterilization

[B058ART13C001]

Moist Heat or Steam Sterilization

[B058ART13C001]

Moist Heat or Steam Sterilization

[B058ART13C001]

Moist Heat or Steam Sterilization

[B058ART13C001]

Moist Heat or Steam Sterilization

[B058ART13C001]

Moist Heat or Steam Sterilization

[B058ART13C001]

Moist Heat or Steam Sterilization

[B058ART13C001]

Moist Heat or Steam Sterilization

[B058ART13C001]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-12-07
• Device Publish Date: 2021-11-29

On-Brand Devices [ART End Cap]

• B058ART13C151: ART End Cap Ø13mm x 15mm (+15)
• B058ART13C101: ART End Cap Ø13mm x 10mm (+10)
• B058ART13C051: ART End Cap Ø13mm x 05mm (+05)
• B058ART13C001: ART End Cap Ø13mm x 00mm (flush)