5.0 mm Wise-Lock Screws, Self Tapping & Self Drilling, Length 85 mm A3-DND-QF-001-WF3

GUDID 08903993271476

Screws are used to affix the plate to the bone

Auxein Medical Private Limited

Orthopaedic fixation plate kit, non-bioabsorbable, sterile
Primary Device ID08903993271476
NIH Device Record Keya58daaf7-a89e-44a1-a5e9-00f718e8a9af
Commercial Distribution StatusIn Commercial Distribution
Brand Name5.0 mm Wise-Lock Screws, Self Tapping & Self Drilling, Length 85 mm
Version Model NumberTI-119.285
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
GS108903993271476 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08903993271476]

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 [5.0 mm Wise-Lock Screws, Self Tapping & Self Drilling, Length 85 mm]

08903993271476Screws are used to affix the plate to the bone
08903993271193Screws are used to affix the plate to the bone

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