174162000

GUDID 10705034018041

SURGICAL TITANIUM MESH MESH, ROUND CURVED 14 x 130mm

DEPUY SPINE, LLC

Metallic spinal fusion cage, non-sterile
Primary Device ID10705034018041
NIH Device Record Keyba679b07-a0d3-48dc-8d6f-863686bf6316
Commercial Distribution Discontinuation2019-04-30
Commercial Distribution StatusNot in Commercial Distribution
Version Model Number174162000
Catalog Number174162000
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
GS110705034018041 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EZXMesh, surgical, metal

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10705034018041]

Moist Heat or Steam Sterilization


[10705034018041]

Moist Heat or Steam Sterilization


[10705034018041]

Moist Heat or Steam Sterilization


[10705034018041]

Moist Heat or Steam Sterilization


[10705034018041]

Moist Heat or Steam Sterilization


[10705034018041]

Moist Heat or Steam Sterilization


[10705034018041]

Moist Heat or Steam Sterilization


[10705034018041]

Moist Heat or Steam Sterilization


[10705034018041]

Moist Heat or Steam Sterilization


[10705034018041]

Moist Heat or Steam Sterilization


[10705034018041]

Moist Heat or Steam Sterilization


[10705034018041]

Moist Heat or Steam Sterilization


[10705034018041]

Moist Heat or Steam Sterilization


[10705034018041]

Moist Heat or Steam Sterilization


[10705034018041]

Moist Heat or Steam Sterilization


[10705034018041]

Moist Heat or Steam Sterilization


[10705034018041]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-04-30
Device Publish Date2015-09-24

Devices Manufactured by DEPUY SPINE, LLC

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10705034577319 - N/A2025-04-11 TAP 4.0mm
10705034577326 - N/A2025-04-11 TAP 4.5mm
10705034577333 - N/A2025-04-11 TAP 5.0mm
10705034577340 - N/A2025-04-11 TAP 6.0mm
10705034577357 - N/A2025-04-11 TAP 7.0mm
10705034577647 - N/A2025-04-11 DRIVER T27
10705034577661 - N/A2025-04-11 DISTRACTOR

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