PANTA PANTAINSTSET

GUDID 10381780125860

The PANTA nail set inclides instrumentation wich are used as a guide for the implantation of PANTA Nail system.The PANTA ankle nail is a straight, cannulated intramedullary nail.

NEWDEAL

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 10381780125860
• NIH Device Record Key: 0b38391a-5129-4924-9270-8d7142b7bc3c
• Commercial Distribution Discontinuation: 2023-03-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: PANTA
• Version Model Number: PANTAINSTSET
• Catalog Number: PANTAINSTSET
• Company DUNS: 536935331
• Company Name: NEWDEAL
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780125860 [Primary]
HIBCC	M248PANTAINSTSET1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050882

FDA Product Code

• HSB: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

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

[10381780125860]

Moist Heat or Steam Sterilization

[10381780125860]

Moist Heat or Steam Sterilization

[10381780125860]

Moist Heat or Steam Sterilization

[10381780125860]

Moist Heat or Steam Sterilization

[10381780125860]

Moist Heat or Steam Sterilization

[10381780125860]

Moist Heat or Steam Sterilization

[10381780125860]

Moist Heat or Steam Sterilization

[10381780125860]

Moist Heat or Steam Sterilization

[10381780125860]

Moist Heat or Steam Sterilization

[10381780125860]

Moist Heat or Steam Sterilization

[10381780125860]

Moist Heat or Steam Sterilization

[10381780125860]

Moist Heat or Steam Sterilization

[10381780125860]

Moist Heat or Steam Sterilization

[10381780125860]

Moist Heat or Steam Sterilization

[10381780125860]

Moist Heat or Steam Sterilization

[10381780125860]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-05-02
• Device Publish Date: 2015-09-24

On-Brand Devices [PANTA]

• 10381780044482: The end cap is made from Titanium alloy and may be inserted into the distal nail threads to prev
• 10381780044567: The NEWDEAL Ankle Nail is a straight, cannulated intramedullary nail available in diameters of 1
• M248500350ND1: The NEWDEAL Ankle Nail is a straight, cannulated intramedullary nail available in diameters of 1
• 10381780044543: The NEWDEAL Ankle Nail is a straight, cannulated intramedullary nail available in diameters of 1
• M248500250ND1: The NEWDEAL Ankle Nail is a straight, cannulated intramedullary nail available in diameters of 1
• M248500180ND1: The NEWDEAL Ankle Nail is a straight, cannulated intramedullary nail available in diameters of 1
• M248500150ND1: The NEWDEAL Ankle Nail is a straight, cannulated intramedullary nail available in diameters of 1
• M248500080ND1: The NEWDEAL Ankle Nail is a straight, cannulated intramedullary nail available in diameters of 1
• M248500050ND1: The NEWDEAL Ankle Nail is a straight, cannulated intramedullary nail available in diameters of 1
• 10381780125860: The PANTA nail set inclides instrumentation wich are used as a guide for the implantation of PAN
• 10381780125891: The complete PANTA removal set includes instruments to be used for the removal of all PANTA nail