5.0mm Wise-Lock Screws, Self Tapping, Length 70 mm A3-DND-QF-001-WF3

GUDID 08903993270844

Screws are used to affix the plate to the bone

Auxein Medical Private Limited

Orthopaedic fixation plate kit, non-bioabsorbable, sterile
Primary Device ID08903993270844
NIH Device Record Key631adfa4-c5d1-4aa4-8b69-4915e174ad02
Commercial Distribution StatusIn Commercial Distribution
Brand Name5.0mm Wise-Lock Screws, Self Tapping, Length 70 mm
Version Model Number119.070
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
GS108903993270844 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08903993270844]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-04-18
Device Publish Date2018-11-30

On-Brand Devices [5.0mm Wise-Lock Screws, Self Tapping, Length 70 mm]

08903993271810Screws are used to affix the plate to the bone
08903993270844Screws are used to affix the plate to the bone

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