Expert Tibia Nial

GUDID 08903993392638

Ø4.4mm Locking Bolt, Self Tapping, Length 28mm, Titanium

Auxein Medical Private Limited

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID08903993392638
NIH Device Record Keyb7ac0754-53c8-412a-a110-8f8ca926f943
Commercial Distribution StatusIn Commercial Distribution
Brand NameExpert Tibia Nial
Version Model NumberTI-520-058-28
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
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
GS108903993392638 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBRod, Fixation, Intramedullary And Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08903993392638]

Moist Heat or Steam Sterilization


[08903993392638]

Moist Heat or Steam Sterilization


[08903993392638]

Moist Heat or Steam Sterilization


[08903993392638]

Moist Heat or Steam Sterilization


[08903993392638]

Moist Heat or Steam Sterilization


[08903993392638]

Moist Heat or Steam Sterilization


[08903993392638]

Moist Heat or Steam Sterilization


[08903993392638]

Moist Heat or Steam Sterilization


[08903993392638]

Moist Heat or Steam Sterilization


[08903993392638]

Moist Heat or Steam Sterilization


[08903993392638]

Moist Heat or Steam Sterilization


[08903993392638]

Moist Heat or Steam Sterilization


[08903993392638]

Moist Heat or Steam Sterilization


[08903993392638]

Moist Heat or Steam Sterilization


[08903993392638]

Moist Heat or Steam Sterilization


[08903993392638]

Moist Heat or Steam Sterilization


[08903993392638]

Moist Heat or Steam Sterilization


[08903993392638]

Moist Heat or Steam Sterilization


[08903993392638]

Moist Heat or Steam Sterilization


[08903993392638]

Moist Heat or Steam Sterilization


[08903993392638]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-29
Device Publish Date2020-10-21

Devices Manufactured by Auxein Medical Private Limited

08903993215548 - 4.5/5.0mm Wise-Lock Broad Dynamic Compression Plate with LC under cuts, 10 Holes2024-12-10 The plates are designed in various length,The plates are contoured to provide a close fit with the Humerus,Femur & Tibia
08903993215555 - 4.5/5.0mm Wise-Lock Broad Dynamic Compression Plate with LC under cuts, 11 Holes2024-12-10 The plates are designed in various length,The plates are contoured to provide a close fit with the Humerus,Femur & Tibia
08903993215562 - 4.5/5.0mm Wise-Lock Broad Dynamic Compression Plate with LC under cuts, 12 Holes2024-12-10 The plates are designed in various length,The plates are contoured to provide a close fit with the Humerus,Femur & Tibia
08903993215579 - 4.5/5.0mm Wise-Lock Broad Dynamic Compression Plate with LC under cuts, 13 Holes2024-12-10 The plates are designed in various length,The plates are contoured to provide a close fit with the Humerus,Femur & Tibia
08903993215586 - 4.5/5.0mm Wise-Lock Broad Dynamic Compression Plate with LC under cuts, 14 Holes2024-12-10 The plates are designed in various length,The plates are contoured to provide a close fit with the Humerus,Femur & Tibia
08903993215593 - 4.5/5.0mm Wise-Lock Broad Dynamic Compression Plate with LC under cuts, 15 Holes2024-12-10 The plates are designed in various length,The plates are contoured to provide a close fit with the Humerus,Femur & Tibia
08903993215609 - 4.5/5.0mm Wise-Lock Broad Dynamic Compression Plate with LC under cuts, 16 Holes2024-12-10 The plates are designed in various length,The plates are contoured to provide a close fit with the Humerus,Femur & Tibia
08903993215616 - 4.5/5.0mm Wise-Lock Broad Dynamic Compression Plate with LC under cuts, 18 Holes2024-12-10 The plates are designed in various length,The plates are contoured to provide a close fit with the Humerus,Femur & Tibia

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