AJAX Nail

GUDID 08903993423615

125° AJAX Nail, Long, Ø12mm x Length 340mm, 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 ID08903993423615
NIH Device Record Key8a7a3d4a-6a5b-4796-9334-8e9ae9405e48
Commercial Distribution StatusIn Commercial Distribution
Brand NameAJAX Nail
Version Model NumberTI-6086L-12-340L
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
GS108903993423615 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDSNail, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08903993423615]

Moist Heat or Steam Sterilization


[08903993423615]

Moist Heat or Steam Sterilization


[08903993423615]

Moist Heat or Steam Sterilization


[08903993423615]

Moist Heat or Steam Sterilization


[08903993423615]

Moist Heat or Steam Sterilization


[08903993423615]

Moist Heat or Steam Sterilization


[08903993423615]

Moist Heat or Steam Sterilization


[08903993423615]

Moist Heat or Steam Sterilization


[08903993423615]

Moist Heat or Steam Sterilization


[08903993423615]

Moist Heat or Steam Sterilization


[08903993423615]

Moist Heat or Steam Sterilization


[08903993423615]

Moist Heat or Steam Sterilization


[08903993423615]

Moist Heat or Steam Sterilization


[08903993423615]

Moist Heat or Steam Sterilization


[08903993423615]

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]

08903993419526130° AJAX Nail, Short, Ø9mm x Length 170mm, Titanium
08903993432181130° AJAX Nail, Long, Ø9mm x Length 380mm, Right, Titanium
08903993432174130° AJAX Nail, Long, Ø9mm x Length 360mm, Right, Titanium
08903993432150130° AJAX Nail, Long, Ø9mm x Length 320mm, Right, Titanium
08903993419915130° AJAX Nail, Long, Ø10mm x Length 280mm, Left, Titanium
08903993419908130° AJAX Nail, Long, Ø10mm x Length 260mm, Left, Titanium
08903993419892130° AJAX Nail, Long, Ø9mm x Length 420mm, Left, Titanium
08903993419885130° AJAX Nail, Long, Ø9mm x Length 400mm, Left, Titanium
08903993419861130° AJAX Nail, Long, Ø9mm x Length 360mm, Left, Titanium
08903993419847130° AJAX Nail, Long, Ø9mm x Length 320mm, Left, Titanium
08903993419830130° AJAX Nail, Long, Ø9mm x Length 300mm, Left, Titanium
08903993419823130° AJAX Nail, Long, Ø9mm x Length 280mm, Left, Titanium
08903993419816130° AJAX Nail, Long, Ø9mm x Length 260mm, Left, Titanium
08903993419632130° AJAX Nail, Short, Ø12mm x Length 240mm, Titanium
08903993419625130° AJAX Nail, Short, Ø12mm x Length 200mm, Titanium
08903993419618130° AJAX Nail, Short, Ø12mm x Length 170mm, Titanium
08903993419595130° AJAX Nail, Short, Ø11mm x Length 200mm, Titanium
08903993419571130° AJAX Nail, Short, Ø10mm x Length 240mm, Titanium
08903993406502130° AJAX Nail, Long, Ø11mm x Length 400mm, Right, Titanium
08903993406465130° AJAX Nail, Long, Ø11mm x Length 320mm, Right, Titanium
08903993406458130° AJAX Nail, Long, Ø11mm x Length 300mm, Right, Titanium
08903993406373130° AJAX Nail, Long, Ø12mm x Length 320mm, Left, Titanium
08903993406359130° AJAX Nail, Long, Ø12mm x Length 280mm, Left, Titanium
08903993406335130° AJAX Nail, Long, Ø11mm x Length 420mm, Left, Titanium
08903993406328130° AJAX Nail, Long, Ø11mm x Length 400mm, Left, Titanium
08903993406281130° AJAX Nail, Long, Ø11mm x Length 320mm, Left, Titanium
08903993406274130° AJAX Nail, Long, Ø11mm x Length 300mm, Left, Titanium
08903993406267130° AJAX Nail, Long, Ø11mm x Length 280mm, Left, Titanium
08903993406250130° AJAX Nail, Long, Ø11mm x Length 260mm, Left, Titanium
08903993396636130° AJAX Nail, Long, Ø10mm x Length 400mm, Right, Titanium
08903993396612130° AJAX Nail, Long, Ø10mm x Length 360mm, Right, Titanium
08903993396605130° AJAX Nail, Long, Ø10mm x Length 340mm, Right, Titanium
08903993396575130° AJAX Nail, Long, Ø10mm x Length 280mm, Right, Titanium
08903993396544130° AJAX Nail, Long, Ø9mm x Length 400mm, Right, Titanium
08903993396476130° AJAX Nail, Long, Ø9mm x Length 260mm, Right, Titanium
08903993396469130° AJAX Nail, Long, Ø10mm x Length 420mm, Left, Titanium
08903993396445130° AJAX Nail, Long, Ø10mm x Length 380mm, Left, Titanium
08903993423684125° AJAX Nail, Long, Ø9mm x Length 300mm, Right, Titanium
08903993423622125° AJAX Nail, Long, Ø12mm x Length 360mm, Left, Titanium
08903993423615125° AJAX Nail, Long, Ø12mm x Length 340mm, Left, Titanium
08903993423578125° AJAX Nail, Long, Ø12mm x Length 260mm, Left, Titanium
08903993423493125° AJAX Nail, Long, Ø11mm x Length 280mm, Left, Titanium
08903993423394125° AJAX Nail, Long, Ø10mm x Length 260mm, Left, Titanium
08903993423387125° AJAX Nail, Long, Ø9mm x Length 420mm, Left, Titanium
08903993423219125° AJAX Nail, Short, Ø10mm x Length 170mm, Titanium
08903993423202125° AJAX Nail, Short, Ø9mm x Length 240mm, Titanium
08903993424018125° AJAX Nail, Long, Ø12mm x Length 420mm, Right, Titanium
08903993423967125° AJAX Nail, Long, Ø12mm x Length 320mm, Right, Titanium
08903993423868125° AJAX Nail, Long, Ø11mm x Length 300mm, Right, Titanium
08903993423769125° AJAX Nail, Long, Ø10mm x Length 280mm, Right, Titanium

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