EPIX Lag Screw 65mm x 11mm 3212-06511

GUDID B2213212065111

Intramedullary And Accessories

Epix Orthopaedics Inc.

Flexible bone nail, sterile
Primary Device IDB2213212065111
NIH Device Record Keybe9ecb97-9e0c-4560-8747-bcabb19c4317
Commercial Distribution StatusIn Commercial Distribution
Brand NameEPIX Lag Screw 65mm x 11mm
Version Model Number3212-06511
Catalog Number3212-06511
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

Length65 Millimeter
Length65 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB2213212065111 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B2213212065111]

Moist Heat or Steam Sterilization


[B2213212065111]

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

Devices Manufactured by Epix Orthopaedics Inc.

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