EPIX Assy, Long Nail 10mm x 320mm Right 3210-32010R

GUDID B221321032010R1

Intramedullary And Accessories

Epix Orthopaedics Inc.

Flexible bone nail, sterile
Primary Device IDB221321032010R1
NIH Device Record Key5a437737-cbf2-4073-b4d1-43912411df8f
Commercial Distribution StatusIn Commercial Distribution
Brand NameEPIX Assy, Long Nail 10mm x 320mm Right
Version Model Number3210-32010R
Catalog Number3210-32010R
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

Length320 Millimeter
Length320 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB221321032010R1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B221321032010R1]

Moist Heat or Steam Sterilization


[B221321032010R1]

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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