Expert Femoral Nail

GUDID 08903993376973

Ø4.8mm Locking Bolt, Self Tapping, Length 42mm, Titanium (For Expert Femoral Nail)

Auxein Medical Private Limited

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID08903993376973
NIH Device Record Keyb8275068-6cf6-42d0-822e-b6774efb7d77
Commercial Distribution StatusIn Commercial Distribution
Brand NameExpert Femoral Nail
Version Model NumberTI-1458-4.8-042
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

Device Identifiers

Device Issuing AgencyDevice ID
GS108903993376973 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBRod, Fixation, Intramedullary And Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08903993376973]

Moist Heat or Steam Sterilization


[08903993376973]

Moist Heat or Steam Sterilization


[08903993376973]

Moist Heat or Steam Sterilization


[08903993376973]

Moist Heat or Steam Sterilization


[08903993376973]

Moist Heat or Steam Sterilization


[08903993376973]

Moist Heat or Steam Sterilization


[08903993376973]

Moist Heat or Steam Sterilization


[08903993376973]

Moist Heat or Steam Sterilization


[08903993376973]

Moist Heat or Steam Sterilization


[08903993376973]

Moist Heat or Steam Sterilization


[08903993376973]

Moist Heat or Steam Sterilization


[08903993376973]

Moist Heat or Steam Sterilization


[08903993376973]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-30
Device Publish Date2020-10-22

On-Brand Devices [ Expert Femoral Nail]

08903993392805Ø4.8mm Locking Bolt, Self Tapping, Length 52mm, Titanium (For Expert Femoral Nail)
08903993392799Ø4.8mm Locking Bolt, Self Tapping, Length 28mm, Titanium (For Expert Femoral Nail)
08903993377055Ø4.8mm Locking Bolt, Self Tapping, Length 58mm, Titanium (For Expert Femoral Nail)
08903993376973Ø4.8mm Locking Bolt, Self Tapping, Length 42mm, Titanium (For Expert Femoral Nail)
08903993376966Ø4.8mm Locking Bolt, Self Tapping, Length 40mm, Titanium (For Expert Femoral Nail)
08903993376942Ø4.8mm Locking Bolt, Self Tapping, Length 36mm, Titanium (For Expert Femoral Nail)
08903993376928Ø4.8mm Locking Bolt, Self Tapping, Length 32mm, Titanium (For Expert Femoral Nail)
08903993376911Ø4.8mm Locking Bolt, Self Tapping, Length 30mm, Titanium (For Expert Femoral Nail)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.