Pediatric Nailing Platform | Femur 10-1504-0942

GUDID 00841132139912

9mm x 420mm Adolescent Nail, Right, Sterile

ORTHOPEDIATRICS CORP.

Femur nail, sterile Femur nail, sterile Femur nail, sterile Femur nail, sterile Femur nail, sterile Femur nail, sterile Femur nail, sterile Femur nail, sterile Femur nail, sterile Femur nail, sterile Femur nail, sterile Femur nail, sterile Femur nail, sterile Femur nail, sterile Femur nail, sterile Femur nail, sterile Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail
Primary Device ID00841132139912
NIH Device Record Key3ff93774-d997-4d49-bcaf-a49953f975c6
Commercial Distribution StatusIn Commercial Distribution
Brand NamePediatric Nailing Platform | Femur
Version Model Number10-1504-0942
Catalog Number10-1504-0942
Company DUNS796416191
Company NameORTHOPEDIATRICS CORP.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841132139912 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00841132139912]

Radiation Sterilization


[00841132139912]

Radiation Sterilization


[00841132139912]

Radiation Sterilization


[00841132139912]

Radiation Sterilization


[00841132139912]

Radiation Sterilization


[00841132139912]

Radiation Sterilization


[00841132139912]

Radiation Sterilization


[00841132139912]

Radiation Sterilization


[00841132139912]

Radiation Sterilization


[00841132139912]

Radiation Sterilization


[00841132139912]

Radiation Sterilization


[00841132139912]

Radiation Sterilization


[00841132139912]

Radiation Sterilization


[00841132139912]

Radiation Sterilization


[00841132139912]

Radiation Sterilization


[00841132139912]

Radiation Sterilization


[00841132139912]

Radiation Sterilization


[00841132139912]

Radiation Sterilization


[00841132139912]

Radiation Sterilization


[00841132139912]

Radiation Sterilization


[00841132139912]

Radiation Sterilization


[00841132139912]

Radiation Sterilization


[00841132139912]

Radiation Sterilization


[00841132139912]

Radiation Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-04
Device Publish Date2020-12-25

On-Brand Devices [Pediatric Nailing Platform | Femur]

0084113214075812mm x 420mm Adolescent Nail, Right, Sterile
0084113214074112mm x 400mm Adolescent Nail, Right, Sterile
0084113214073412mm x 380mm Adolescent Nail, Right, Sterile
0084113214072712mm x 360mm Adolescent Nail, Right, Sterile
0084113214071012mm x 340mm Adolescent Nail, Right, Sterile
0084113214070312mm x 320mm Adolescent Nail, Right, Sterile
0084113214069712mm x 300mm Adolescent Nail, Right, Sterile
0084113214068012mm x 420mm Adolescent Nail, Left, Sterile
0084113214067312mm x 400mm Adolescent Nail, Left, Sterile
0084113214066612mm x 380mm Adolescent Nail, Left, Sterile
0084113214065912mm x 360mm Adolescent Nail, Left, Sterile
0084113214064212mm x 340mm Adolescent Nail, Left, Sterile
0084113214063512mm x 320mm Adolescent Nail, Left, Sterile
0084113214062812mm x 300mm Adolescent Nail, Left, Sterile
0084113214047511mm x 420mm Adolescent Nail, Right, Sterile
0084113214046811mm x 400mm Adolescent Nail, Right, Sterile
0084113214045111mm x 380mm Adolescent Nail, Right, Sterile
0084113214044411mm x 360mm Adolescent Nail, Right, Sterile
0084113214043711mm x 340mm Adolescent Nail, Right, Sterile
0084113214042011mm x 320mm Adolescent Nail, Right, Sterile
0084113214041311mm x 300mm Adolescent Nail, Right, Sterile
0084113214040611mm x 420mm Adolescent Nail, Left, Sterile
0084113214039011mm x 400mm Adolescent Nail, Left, Sterile
0084113214038311mm x 380mm Adolescent Nail, Left, Sterile
0084113214037611mm x 360mm Adolescent Nail, Left, Sterile
0084113214036911mm x 340mm Adolescent Nail, Left, Sterile
0084113214035211mm x 320mm Adolescent Nail, Left, Sterile
0084113214034511mm x 300mm Adolescent Nail, Left, Sterile
0084113214019210mm x 420mm Adolescent Nail, Right, Sterile
0084113214018510mm x 400mm Adolescent Nail, Right, Sterile
0084113214017810mm x 380mm Adolescent Nail, Right, Sterile
0084113214016110mm x 360mm Adolescent Nail, Right, Sterile
0084113214015410mm x 340mm Adolescent Nail, Right, Sterile
0084113214014710mm x 320mm Adolescent Nail, Right, Sterile
0084113214013010mm x 300mm Adolescent Nail, Right, Sterile
0084113214012310mm x 420mm Adolescent Nail, Left, Sterile
0084113214011610mm x 400mm Adolescent Nail, Left, Sterile
0084113214010910mm x 380mm Adolescent Nail, Left, Sterile
0084113214009310mm x 360mm Adolescent Nail, Left, Sterile
0084113214008610mm x 340mm Adolescent Nail, Left, Sterile
0084113214007910mm x 320mm Adolescent Nail, Left, Sterile
0084113214006210mm x 300mm Adolescent Nail, Left, Sterile
008411321399129mm x 420mm Adolescent Nail, Right, Sterile
008411321399059mm x 400mm Adolescent Nail, Right, Sterile
008411321398999mm x 380mm Adolescent Nail, Right, Sterile
008411321398829mm x 360mm Adolescent Nail, Right, Sterile
008411321398759mm x 340mm Adolescent Nail, Right, Sterile
008411321398689mm x 320mm Adolescent Nail, Right, Sterile
008411321398519mm x 300mm Adolescent Nail, Right, Sterile
008411321398449mm x 280mm Adolescent Nail, Right, Sterile

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