2.4mm Variable Angle Two-Column Volar Distal Radius Plate, Narrow (Left), 6 head

GUDID 08903993537305

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

Auxein Medical Private Limited

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
Primary Device ID08903993537305
NIH Device Record Key7a6f45d1-090d-40f3-8b69-f125e1aa0478
Commercial Distribution StatusIn Commercial Distribution
Brand Name2.4mm Variable Angle Two-Column Volar Distal Radius Plate, Narrow (Left), 6 head
Version Model NumberTi-M546.008LS
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
GS108903993537305 [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

On-Brand Devices [2.4mm Variable Angle Two-Column Volar Distal Radius Plate, Narrow (Left), 6 head]

089039935373052.4mm Variable Angle Two-Column Volar Distal Radius Plate, Narrow (Left), 6 head Holes,8 holes
089039935372992.4mm Variable Angle Two-Column Volar Distal Radius Plate, Narrow (Left), 6 head Holes,7 holes
089039935372822.4mm Variable Angle Two-Column Volar Distal Radius Plate, Narrow (Left), 6 head Holes,6 holes
089039935372752.4mm Variable Angle Two-Column Volar Distal Radius Plate, Narrow (Left), 6 head Holes,5 holes
089039935372682.4mm Variable Angle Two-Column Volar Distal Radius Plate, Narrow (Left), 6 head Holes,4 holes
089039935372512.4mm Variable Angle Two-Column Volar Distal Radius Plate, Narrow (Left), 6 head Holes,3 holes
089039935372442.4mm Variable Angle Two-Column Volar Distal Radius Plate, Narrow (Left), 6 head Holes,2 holes
089039934390742.4mm Variable Angle Two-Column Volar Distal Radius Plate, Narrow (Left), 6 head Holes,8 holes
089039934390672.4mm Variable Angle Two-Column Volar Distal Radius Plate, Narrow (Left), 6 head Holes,7 holes
089039934122992.4mm Variable Angle Two-Column Volar Distal Radius Plate, Narrow (Left), 6 head Holes,6 holes
089039933739032.4mm Variable Angle Two-Column Volar Distal Radius Plate, Narrow (Left), 6 head Holes,4 holes
089039933738972.4mm Variable Angle Two-Column Volar Distal Radius Plate, Narrow (Left), 6 head Holes,2 holes
089039933683502.4mm Variable Angle Two-Column Volar Distal Radius Plate, Narrow (Left), 6 head Holes,5 holes
089039933683362.4mm Variable Angle Two-Column Volar Distal Radius Plate, Narrow (Left), 6 head Holes,3 holes
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.