EPIX Distal Screw 85.0mm x 5mm 9001-08505

GUDID B2219001085051

Intramedullary And Accessories

Epix Orthopaedics Inc.

Flexible bone nail, sterile
Primary Device IDB2219001085051
NIH Device Record Keya8c31d79-6952-4ec2-893a-4dfbb607638a
Commercial Distribution StatusIn Commercial Distribution
Brand NameEPIX Distal Screw 85.0mm x 5mm
Version Model Number9001-08505
Catalog Number9001-08505
Company DUNS084913303
Company NameEpix Orthopaedics Inc.
Device Count1
DM Exempttrue
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(844)710-9105
Emailepixortho@icloud.com
Phone+1(844)710-9105
Emailepixortho@icloud.com

Device Dimensions

Length80 Millimeter
Length80 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB2219001085051 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B2219001085051]

Moist Heat or Steam Sterilization


[B2219001085051]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-13
Device Publish Date2019-03-05

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