AJAX Nail

GUDID 08903993423639

125° AJAX Nail, Long, Ø12mm x Length 380mm, Left, Titanium

Auxein Medical Private Limited

Femur nail, non-sterile Femur nail, non-sterile Femur nail, non-sterile Femur nail, non-sterile Femur nail, non-sterile Femur nail, non-sterile Femur nail, non-sterile Femur nail, non-sterile Femur nail, non-sterile Femur nail, non-sterile Femur nail, non-sterile Femur nail, non-sterile Femur nail, non-sterile Femur nail, non-sterile Femur nail, non-sterile
Primary Device ID08903993423639
NIH Device Record Keye6a26609-e433-43f4-9d18-372282fb329f
Commercial Distribution StatusIn Commercial Distribution
Brand NameAJAX Nail
Version Model NumberTI-6086L-12-380L
Company DUNS872194615
Company NameAuxein Medical Private Limited
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+919910643638
Emailinfo@auxein.com
Phone+919910643638
Emailinfo@auxein.com
Phone+919910643638
Emailinfo@auxein.com
Phone+919910643638
Emailinfo@auxein.com
Phone+919910643638
Emailinfo@auxein.com
Phone+919910643638
Emailinfo@auxein.com
Phone+919910643638
Emailinfo@auxein.com
Phone+919910643638
Emailinfo@auxein.com
Phone+919910643638
Emailinfo@auxein.com
Phone+919910643638
Emailinfo@auxein.com
Phone+919910643638
Emailinfo@auxein.com
Phone+919910643638
Emailinfo@auxein.com
Phone+919910643638
Emailinfo@auxein.com
Phone+919910643638
Emailinfo@auxein.com
Phone+919910643638
Emailinfo@auxein.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108903993423639 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDSNail, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08903993423639]

Moist Heat or Steam Sterilization


[08903993423639]

Moist Heat or Steam Sterilization


[08903993423639]

Moist Heat or Steam Sterilization


[08903993423639]

Moist Heat or Steam Sterilization


[08903993423639]

Moist Heat or Steam Sterilization


[08903993423639]

Moist Heat or Steam Sterilization


[08903993423639]

Moist Heat or Steam Sterilization


[08903993423639]

Moist Heat or Steam Sterilization


[08903993423639]

Moist Heat or Steam Sterilization


[08903993423639]

Moist Heat or Steam Sterilization


[08903993423639]

Moist Heat or Steam Sterilization


[08903993423639]

Moist Heat or Steam Sterilization


[08903993423639]

Moist Heat or Steam Sterilization


[08903993423639]

Moist Heat or Steam Sterilization


[08903993423639]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-05
Device Publish Date2020-10-28

On-Brand Devices [AJAX Nail]

08903993432167130° AJAX Nail, Long, Ø9mm x Length 340mm, Right, Titanium
08903993419878130° AJAX Nail, Long, Ø9mm x Length 380mm, Left, Titanium
08903993419854130° AJAX Nail, Long, Ø9mm x Length 340mm, Left, Titanium
08903993419601130° AJAX Nail, Short, Ø11mm x Length 240mm, Titanium
08903993419588130° AJAX Nail, Short, Ø11mm x Length 170mm, Titanium
08903993419564130° AJAX Nail, Short, Ø10mm x Length 200mm, Titanium
08903993419557130° AJAX Nail, Short, Ø10mm x Length 170mm, Titanium
08903993419540130° AJAX Nail, Short, Ø9mm x Length 240mm, Titanium
08903993419533130° AJAX Nail, Short, Ø9mm x Length 200mm, Titanium
08903993406601130° AJAX Nail, Long, Ø12mm x Length 420mm, Right, Titanium
08903993406595130° AJAX Nail, Long, Ø12mm x Length 400mm, Right, Titanium
08903993406588130° AJAX Nail, Long, Ø12mm x Length 380mm, Right, Titanium
08903993406571130° AJAX Nail, Long, Ø12mm x Length 360mm, Right, Titanium
08903993406564130° AJAX Nail, Long, Ø12mm x Length 340mm, Right, Titanium
08903993406557130° AJAX Nail, Long, Ø12mm x Length 320mm, Right, Titanium
08903993406540130° AJAX Nail, Long, Ø12mm x Length 300mm, Right, Titanium
08903993406533130° AJAX Nail, Long, Ø12mm x Length 280mm, Right, Titanium
08903993406526130° AJAX Nail, Long, Ø12mm x Length 260mm, Right, Titanium
08903993406519130° AJAX Nail, Long, Ø11mm x Length 420mm, Right, Titanium
08903993406496130° AJAX Nail, Long, Ø11mm x Length 380mm, Right, Titanium
08903993406489130° AJAX Nail, Long, Ø11mm x Length 360mm, Right, Titanium
08903993406472130° AJAX Nail, Long, Ø11mm x Length 340mm, Right, Titanium
08903993406441130° AJAX Nail, Long, Ø11mm x Length 280mm, Right, Titanium
08903993406434130° AJAX Nail, Long, Ø11mm x Length 260mm, Right, Titanium
08903993406427130° AJAX Nail, Long, Ø12mm x Length 420mm, Left, Titanium
08903993406410130° AJAX Nail, Long, Ø12mm x Length 400mm, Left, Titanium
08903993406403130° AJAX Nail, Long, Ø12mm x Length 380mm, Left, Titanium
08903993406397130° AJAX Nail, Long, Ø12mm x Length 360mm, Left, Titanium
08903993406380130° AJAX Nail, Long, Ø12mm x Length 340mm, Left, Titanium
08903993406366130° AJAX Nail, Long, Ø12mm x Length 300mm, Left, Titanium
08903993406342130° AJAX Nail, Long, Ø12mm x Length 260mm, Left, Titanium
08903993406311130° AJAX Nail, Long, Ø11mm x Length 380mm, Left, Titanium
08903993406304130° AJAX Nail, Long, Ø11mm x Length 360mm, Left, Titanium
08903993406298130° AJAX Nail, Long, Ø11mm x Length 340mm, Left, Titanium
08903993396643130° AJAX Nail, Long, Ø10mm x Length 420mm, Right, Titanium
08903993396629130° AJAX Nail, Long, Ø10mm x Length 380mm, Right, Titanium
08903993396599130° AJAX Nail, Long, Ø10mm x Length 320mm, Right, Titanium
08903993396582130° AJAX Nail, Long, Ø10mm x Length 300mm, Right, Titanium
08903993396568130° AJAX Nail, Long, Ø10mm x Length 260mm, Right, Titanium
08903993396551130° AJAX Nail, Long, Ø9mm x Length 420mm, Right, Titanium
08903993396490130° AJAX Nail, Long, Ø9mm x Length 300mm, Right, Titanium
08903993396483130° AJAX Nail, Long, Ø9mm x Length 280mm, Right, Titanium
08903993396452130° AJAX Nail, Long, Ø10mm x Length 400mm, Left, Titanium
08903993396438130° AJAX Nail, Long, Ø10mm x Length 360mm, Left, Titanium
08903993396421130° AJAX Nail, Long, Ø10mm x Length 340mm, Left, Titanium
08903993396414130° AJAX Nail, Long, Ø10mm x Length 320mm, Left, Titanium
08903993396407130° AJAX Nail, Long, Ø10mm x Length 300mm, Left, Titanium
08903993423752125° AJAX Nail, Long, Ø10mm x Length 260mm, Right, Titanium
08903993423745125° AJAX Nail, Long, Ø9mm x Length 420mm, Right, Titanium
08903993423738125° AJAX Nail, Long, Ø9mm x Length 400mm, Right, Titanium

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