3.5mm Wise-Lock Medial Distal Tibia Plate, 8 Holes - Right A3-DND-QF-001-WF3

GUDID 08903993203569

The plates are designed in right and left configurations, as well as various length configurations. The plates are contoured to provide a close fit with the distal tibia

Auxein Medical Private Limited

Orthopaedic fixation plate kit, non-bioabsorbable, sterile
Primary Device ID08903993203569
NIH Device Record Key37b2579e-df23-4f52-8e9b-ef87fd334f84
Commercial Distribution StatusIn Commercial Distribution
Brand Name3.5mm Wise-Lock Medial Distal Tibia Plate, 8 Holes - Right
Version Model Number746.108R
Catalog NumberA3-DND-QF-001-WF3
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone9910643638
EmailINFO@AUXEIN.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS108903993203569 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08903993203569]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-04-18
Device Publish Date2018-11-27

On-Brand Devices [3.5mm Wise-Lock Medial Distal Tibia Plate, 8 Holes - Right ]

08903993203682The plates are designed in right and left configurations, as well as various length configura
08903993203569The plates are designed in right and left configurations, as well as various length configura

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