2.4mm Variable Angle Two-Column Volar Distal Radius Plate, Wide (Left), 7 head H

GUDID 08903993537671

2.4mm Variable Angle Two-Column Volar Distal Radius Plate, Wide (Left), 7 head Holes,3 holes

Auxein Medical Private Limited

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
Primary Device ID08903993537671
NIH Device Record Keyeeb704a6-12e0-47d8-97fc-9b5c716ff064
Commercial Distribution StatusIn Commercial Distribution
Brand Name2.4mm Variable Angle Two-Column Volar Distal Radius Plate, Wide (Left), 7 head H
Version Model NumberTi-548.203RS
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+91 9910643638
Emailinfo@auxein.com
Phone+91 9910643638
Emailinfo@auxein.com
Phone+91 9910643638
Emailinfo@auxein.com
Phone+91 9910643638
Emailinfo@auxein.com
Phone+91 9910643638
Emailinfo@auxein.com
Phone+91 9910643638
Emailinfo@auxein.com
Phone+91 9910643638
Emailinfo@auxein.com
Phone+91 9910643638
Emailinfo@auxein.com
Phone+91 9910643638
Emailinfo@auxein.com
Phone+91 9910643638
Emailinfo@auxein.com
Phone+91 9910643638
Emailinfo@auxein.com
Phone+91 9910643638
Emailinfo@auxein.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108903993537671 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-05
Device Publish Date2022-04-27

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089039933578592.4mm Variable Angle Two-Column Volar Distal Radius Plate, Wide (Left), 7 head Holes,5 holes
089039933578422.4mm Variable Angle Two-Column Volar Distal Radius Plate, Wide (Left), 7 head Holes,4 holes
089039933578352.4mm Variable Angle Two-Column Volar Distal Radius Plate, Wide (Left), 7 head Holes,3 holes
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