174149000

GUDID 10705034017877

SURGICAL TITANIUM MESH 17X22MM OVAL 70mm

DEPUY SPINE, LLC

Metallic spinal fusion cage, non-sterile
Primary Device ID10705034017877
NIH Device Record Key0d541d5f-56d0-4755-9c62-064936ddd3ae
Commercial Distribution StatusIn Commercial Distribution
Version Model Number174149000
Catalog Number174149000
Company DUNS107105876
Company NameDEPUY SPINE, LLC
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 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(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS110705034017877 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EZXMesh, surgical, metal

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10705034017877]

Moist Heat or Steam Sterilization


[10705034017877]

Moist Heat or Steam Sterilization


[10705034017877]

Moist Heat or Steam Sterilization


[10705034017877]

Moist Heat or Steam Sterilization


[10705034017877]

Moist Heat or Steam Sterilization


[10705034017877]

Moist Heat or Steam Sterilization


[10705034017877]

Moist Heat or Steam Sterilization


[10705034017877]

Moist Heat or Steam Sterilization


[10705034017877]

Moist Heat or Steam Sterilization


[10705034017877]

Moist Heat or Steam Sterilization


[10705034017877]

Moist Heat or Steam Sterilization


[10705034017877]

Moist Heat or Steam Sterilization


[10705034017877]

Moist Heat or Steam Sterilization


[10705034017877]

Moist Heat or Steam Sterilization


[10705034017877]

Moist Heat or Steam Sterilization


[10705034017877]

Moist Heat or Steam Sterilization


[10705034017877]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-06
Device Publish Date2015-09-24

Devices Manufactured by DEPUY SPINE, LLC

10705034575124 - N/A2024-09-20 MODIFIED INSTRUMENT POWER POLY DRIVER
10705034576428 - N/A2024-09-20 MODIFIED INSTRUMENT TAP
10705034576473 - N/A2024-09-20 MODIFIED INSTRUMENT TAP
10705034576480 - N/A2024-09-20 MODIFIED INSTRUMENT DRIVER
10705034576534 - N/A2024-09-20 MODIFIED INSTRUMENT TAP
10705034576633 - N/A2024-09-19 MODIFIED INSTRUMENT OSTEOTOME
10705034576657 - N/A2024-09-19 MODIFIED INSTRUMENT DISTRACTOR LEG, SHORT
10705034576688 - N/A2024-09-19 MODIFIED INSTRUMENT ACDF SHIM

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