2.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Right), 6 h

GUDID 08903993391143

2.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Right), 6 head Holes,8 holes

Auxein Medical Private Limited

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Primary Device ID08903993391143
NIH Device Record Key125cb2e9-daf9-413c-9d47-10b027401535
Commercial Distribution StatusIn Commercial Distribution
Brand Name2.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Right), 6 h
Version Model NumberTi-546.208R
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+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
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
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
GS108903993391143 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08903993391143]

Moist Heat or Steam Sterilization

[08903993391143]

Moist Heat or Steam Sterilization

[08903993391143]

Moist Heat or Steam Sterilization

[08903993391143]

Moist Heat or Steam Sterilization

[08903993391143]

Moist Heat or Steam Sterilization

[08903993391143]

Moist Heat or Steam Sterilization

[08903993391143]

Moist Heat or Steam Sterilization

[08903993391143]

Moist Heat or Steam Sterilization

[08903993391143]

Moist Heat or Steam Sterilization

[08903993391143]

Moist Heat or Steam Sterilization

[08903993391143]

Moist Heat or Steam Sterilization

[08903993391143]

Moist Heat or Steam Sterilization

[08903993391143]

Moist Heat or Steam Sterilization

[08903993391143]

Moist Heat or Steam Sterilization

[08903993391143]

Moist Heat or Steam Sterilization

[08903993391143]

Moist Heat or Steam Sterilization

[08903993391143]

Moist Heat or Steam Sterilization

[08903993391143]

Moist Heat or Steam Sterilization

[08903993391143]

Moist Heat or Steam Sterilization

[08903993391143]

Moist Heat or Steam Sterilization

[08903993391143]

Moist Heat or Steam Sterilization

[08903993391143]

Moist Heat or Steam Sterilization

[08903993391143]

Moist Heat or Steam Sterilization

[08903993391143]

Moist Heat or Steam Sterilization

[08903993391143]

Moist Heat or Steam Sterilization

[08903993391143]

Moist Heat or Steam Sterilization

[08903993391143]

Moist Heat or Steam Sterilization

[08903993391143]

Moist Heat or Steam Sterilization

[08903993391143]

Moist Heat or Steam Sterilization

[08903993391143]

Moist Heat or Steam Sterilization

[08903993391143]

Moist Heat or Steam Sterilization

[08903993391143]

Moist Heat or Steam Sterilization

[08903993391143]

Moist Heat or Steam Sterilization

[08903993391143]

Moist Heat or Steam Sterilization

[08903993391143]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-09
Device Publish Date2022-04-30

On-Brand Devices [2.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Right), 6 h]

089039935375102.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Right), 6 head Holes,8 hole
089039935375032.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Right), 6 head Holes,7 hole
089039935374972.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Right), 6 head Holes,6 hole
089039935374802.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Right), 6 head Holes,5 hole
089039935374732.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Right), 6 head Holes,4 hole
089039935374662.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Right), 6 head Holes,3 hole
089039933911432.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Right), 6 head Holes,8 hole
089039933911362.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Right), 6 head Holes,7 hole
089039933911292.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Right), 6 head Holes,6 hole
089039933590682.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Right), 6 head Holes,5 hole
089039933590512.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Right), 6 head Holes,4 hole
089039933588562.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Right), 6 head Holes,3 hole
089039933588492.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Right), 6 head Holes,2 hole
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.