2.4mm Wise-Lock distal radius volar plate, Extra-long, (4 head holes), 8 holes

GUDID 08903993200742

2.4mm Wise-Lock distal radius volar plate, Extra-long, (4 head holes), 8 holes

Auxein Medical Private Limited

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Primary Device ID08903993200742
NIH Device Record Key62ee4311-1d25-450d-8eef-21e22a1f3d3e
Commercial Distribution StatusIn Commercial Distribution
Brand Name2.4mm Wise-Lock distal radius volar plate, Extra-long, (4 head holes), 8 holes
Version Model NumberTi-M16.08
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

Device Identifiers

Device Issuing AgencyDevice ID
GS108903993200742 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08903993200742]

Moist Heat or Steam Sterilization


[08903993200742]

Moist Heat or Steam Sterilization


[08903993200742]

Moist Heat or Steam Sterilization


[08903993200742]

Moist Heat or Steam Sterilization


[08903993200742]

Moist Heat or Steam Sterilization


[08903993200742]

Moist Heat or Steam Sterilization


[08903993200742]

Moist Heat or Steam Sterilization


[08903993200742]

Moist Heat or Steam Sterilization


[08903993200742]

Moist Heat or Steam Sterilization


[08903993200742]

Moist Heat or Steam Sterilization


[08903993200742]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-09
Device Publish Date2022-04-29

On-Brand Devices [2.4mm Wise-Lock distal radius volar plate, Extra-long, (4 head holes), 8 holes]

089039935372132.4mm Wise-Lock distal radius volar plate, Extra-long, (4 head holes), 8 holes
089039932007422.4mm Wise-Lock distal radius volar plate, Extra-long, (4 head holes), 8 holes

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