PANTA XL 510005ND

GUDID M248510005ND1

The long end cap is made from Titanium alloy and may be inserted into the distal nail threads to prevent tissue ingrowth and facilitate future nail removal.

NEWDEAL

Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap

• Primary Device ID: M248510005ND1
• NIH Device Record Key: a65205ff-0541-4fdd-8563-58fd5f272dcf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PANTA XL
• Version Model Number: 510005ND
• Catalog Number: 510005ND
• 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: 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: 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

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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780044581 [Primary]
HIBCC	M248510005ND1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091788

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: 5
• Public Version Date: 2021-04-07
• Device Publish Date: 2017-10-09

On-Brand Devices [PANTA XL]

• M248510005ND1: The long end cap is made from Titanium alloy and may be inserted into the distal nail threads to
• M248510004ND1: The long end cap is made from Titanium alloy and may be inserted into the distal nail threads to
• M248510341ND1: The NEWDEAL Ankle Nail is a straight, cannulated intramedullary nail available in diameters of 1
• M248510311ND1: The NEWDEAL Ankle Nail is a straight, cannulated intramedullary nail available in diameters of 1
• M248510241ND1: The NEWDEAL Ankle Nail is a straight, cannulated intramedullary nail available in diameters of 1
• M248510211ND1: The NEWDEAL Ankle Nail is a straight, cannulated intramedullary nail available in diameters of 1
• M248510141ND1: The NEWDEAL Ankle Nail is a straight, cannulated intramedullary nail available in diameters of 1
• M248510111ND1: The NEWDEAL Ankle Nail is a straight, cannulated intramedullary nail available in diameters of 1