Panta® 2 PAN-1010-10150

GUDID 10381780504306

Arthrodesis Nail System Nail, ø10mm X 150mm

Ascension Orthopedics, Inc.

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• Primary Device ID: 10381780504306
• NIH Device Record Key: 8356fb53-92c2-41c6-a5f4-103df7187ce6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Panta® 2
• Version Model Number: PAN-1010-10150
• Catalog Number: PAN-1010-10150
• 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
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780504306 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181639

FDA Product Code

• HSB: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-12-08
• Device Publish Date: 2018-11-13

On-Brand Devices [Panta® 2]

• 10381780505648: Arthrodesis Nail System Drill Guide, ø4.1mm, Tibial
• 10381780505631: Arthrodesis Nail System Drill Guide, ø4.1mm, Calcaneal
• 10381780505624: Arthrodesis Nail System Soft Tissue Protector, ø7mm, Tibia
• 10381780505617: Arthrodesis Nail System Soft Tissue Protector, ø7mm, Calcaneal
• 10381780505600: Arthrodesis Nail System Compression Rod Drill Guide, ø5mm
• 10381780505495: Arthrodesis Nail System External Protection Sleeve ø13.5mm
• 10381780505488: Arthrodesis Nail System Central Protection Sleeve ø9mm
• 10381780505471: Arthrodesis Nail System Internal Protection Sleeve ø3.2mm
• 10381780505808: Arthrodesis Nail System Tibial Drill, ø4.1mm
• 10381780505792: Arthrodesis Nail System Long Calcaneal Drill, ø4.1mm
• 10381780505785: Arthrodesis Nail System Short Calcaneal Drill, ø4.1mm
• 10381780505365: Arthrodesis Nail System End Cap
• 10381780505372: Arthrodesis Nail System End Cap
• 10381780505839: Arthrodesis Nail System Screw Caddy Lid
• 10381780505761: Arthrodesis Nail System Screw Case Lid
• 10381780505754: Arthrodesis Nail System Screw Case
• 10381780505747: Arthrodesis Nail System Panta 2 Lid
• 10381780505730: Arthrodesis Nail System Targeting Guide Tray
• 10381780505723: Arthrodesis Nail System Targeting Guide and Compression Device Case
• 10381780505716: Arthrodesis Nail System Nail and Screw Prep Case
• 10381780505709: Arthrodesis Nail System Screw Caddy
• 10381780504450: Arthrodesis Nail System Nail, ø13mm X 240mm
• 10381780504443: Arthrodesis Nail System Nail, ø13mm X 210mm
• 10381780504436: Arthrodesis Nail System Nail, ø13mm X 180mm
• 10381780504429: Arthrodesis Nail System Nail, ø13mm X 150mm
• 10381780504412: Arthrodesis Nail System Nail, ø12mm X 240mm
• 10381780504405: Arthrodesis Nail System Nail, ø12mm X 210mm
• 10381780504399: Arthrodesis Nail System Nail, ø12mm X 180mm
• 10381780504382: Arthrodesis Nail System Nail, ø12mm X 150mm
• 10381780504375: Arthrodesis Nail System Nail, ø11mm X 240mm
• 10381780504368: Arthrodesis Nail System Nail, ø11mm X 210mm
• 10381780504351: Arthrodesis Nail System Nail, ø11mm X 180mm
• 10381780504344: Arthrodesis Nail System Nail, ø11mm X 150mm
• 10381780504337: Arthrodesis Nail System Nail, ø10mm X 240mm
• 10381780504320: Arthrodesis Nail System Nail, ø10mm X 210mm
• 10381780504313: Arthrodesis Nail System Nail, ø10mm X 180mm
• 10381780504306: Arthrodesis Nail System Nail, ø10mm X 150mm
• 10381780505778: Arthrodesis Nail System T-Handle with AO Quick Connect
• 10381780505822: Arthrodesis Nail System Cannulated Drill ø9mm x 185mm
• 10381780505815: Arthrodesis Nail System Cannulated Drill ø7mm x 185mm
• 10381780505693: Arthrodesis Nail System K-Wire, ø2.5mm x 150mm
• 10381780505686: Arthrodesis Nail System Target Guide Support
• 10381780505679: Arthrodesis Nail System AO Driver Shaft - 3.5mm Hex Screwdriver, Self-Retaining
• 10381780505662: Arthrodesis Nail System 4.1mm Trocar
• 10381780505655: Arthrodesis Nail System Tissue Protector Removal Tool
• 10381780505594: Arthrodesis Nail System Compression Rod, ø5mm
• 10381780505587: Arthrodesis Nail System Depth gauge
• 10381780505570: Arthrodesis Nail System Compression Wheel
• 10381780505563: Arthrodesis Nail System Compression Device
• 10381780505556: Arthrodesis Nail System Lock Screw