Panta® 2 Arthrodesis Nail System PAN-1010-2645NS

GUDID 10381780529088

Partially Threaded C-Screw

Ascension Orthopedics, Inc.

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 10381780529088
• NIH Device Record Key: 1818cb19-5ee2-4051-adad-363d0b74f43c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Panta® 2 Arthrodesis Nail System
• Version Model Number: PAN-1010-2645NS
• Catalog Number: PAN-1010-2645NS
• Company DUNS: 942377524
• Company Name: Ascension Orthopedics, 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: false
• 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: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Dimensions

• Length: 45 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780529088 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181639

FDA Product Code

• HSB: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

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

[10381780529088]

Moist Heat or Steam Sterilization

[10381780529088]

Moist Heat or Steam Sterilization

[10381780529088]

Moist Heat or Steam Sterilization

[10381780529088]

Moist Heat or Steam Sterilization

[10381780529088]

Moist Heat or Steam Sterilization

[10381780529088]

Moist Heat or Steam Sterilization

[10381780529088]

Moist Heat or Steam Sterilization

[10381780529088]

Moist Heat or Steam Sterilization

[10381780529088]

Moist Heat or Steam Sterilization

[10381780529088]

Moist Heat or Steam Sterilization

[10381780529088]

Moist Heat or Steam Sterilization

[10381780529088]

Moist Heat or Steam Sterilization

[10381780529088]

Moist Heat or Steam Sterilization

[10381780529088]

Moist Heat or Steam Sterilization

[10381780529088]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-06-17
• Device Publish Date: 2020-06-09

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