PANTA XL 510141ND

GUDID M248510141ND1

The NEWDEAL Ankle Nail is a straight, cannulated intramedullary nail available in diameters of 10mm, 11mm, 12mm and 13mm, and lengths of 150mm, 180mm, 210mm and 240mm. Holes in the nail allow for proximal and distal locking, using locking cortical screws 5mm diameter, 20 to 110mm long. The nail is made from Titanium alloy.

NEWDEAL

Arthrodesis nail
Primary Device IDM248510141ND1
NIH Device Record Key7c563613-2311-4a1c-9bac-d5f15281d5ce
Commercial Distribution StatusIn Commercial Distribution
Brand NamePANTA XL
Version Model Number510141ND
Catalog Number510141ND
Company DUNS536935331
Company NameNEWDEAL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com

Device Dimensions

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Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place

Device Identifiers

Device Issuing AgencyDevice ID
GS110381780044604 [Primary]
HIBCCM248510141ND1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-12-08
Device Publish Date2017-10-09

On-Brand Devices [PANTA XL]

M248510005ND1The long end cap is made from Titanium alloy and may be inserted into the distal nail threads to
M248510004ND1The long end cap is made from Titanium alloy and may be inserted into the distal nail threads to
M248510341ND1The NEWDEAL Ankle Nail is a straight, cannulated intramedullary nail available in diameters of 1
M248510311ND1The NEWDEAL Ankle Nail is a straight, cannulated intramedullary nail available in diameters of 1
M248510241ND1The NEWDEAL Ankle Nail is a straight, cannulated intramedullary nail available in diameters of 1
M248510211ND1The NEWDEAL Ankle Nail is a straight, cannulated intramedullary nail available in diameters of 1
M248510141ND1The NEWDEAL Ankle Nail is a straight, cannulated intramedullary nail available in diameters of 1
M248510111ND1The NEWDEAL Ankle Nail is a straight, cannulated intramedullary nail available in diameters of 1
M248PANTAXLSET1The PANTA XL nail set inclides instrumentation wich are used as a guide for the implantation of

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