EPIX Distal Screw 32.5mm x 5mm 9001-03205

GUDID B2219001032051

Intramedullary And Accessories

Epix Orthopaedics Inc.

Flexible bone nail, sterile
Primary Device IDB2219001032051
NIH Device Record Key847a1925-50ba-459b-b388-016633d1f200
Commercial Distribution StatusIn Commercial Distribution
Brand NameEPIX Distal Screw 32.5mm x 5mm
Version Model Number9001-03205
Catalog Number9001-03205
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

Length32.5 Millimeter
Length32.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB2219001032051 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B2219001032051]

Moist Heat or Steam Sterilization


[B2219001032051]

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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