176202006

GUDID 10705034036496

SURGICAL TITANIUM MESH MESH ST 12X23 OBLONG TRPZD 6 x 8mm

DEPUY SPINE, LLC

Metallic spinal fusion cage, non-sterile
Primary Device ID10705034036496
NIH Device Record Key133da22c-384e-4e2e-803f-b952d6c6974d
Commercial Distribution StatusIn Commercial Distribution
Version Model Number176202006
Catalog Number176202006
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
GS110705034036496 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EZXMesh, surgical, metal

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10705034036496]

Moist Heat or Steam Sterilization


[10705034036496]

Moist Heat or Steam Sterilization


[10705034036496]

Moist Heat or Steam Sterilization


[10705034036496]

Moist Heat or Steam Sterilization


[10705034036496]

Moist Heat or Steam Sterilization


[10705034036496]

Moist Heat or Steam Sterilization


[10705034036496]

Moist Heat or Steam Sterilization


[10705034036496]

Moist Heat or Steam Sterilization


[10705034036496]

Moist Heat or Steam Sterilization


[10705034036496]

Moist Heat or Steam Sterilization


[10705034036496]

Moist Heat or Steam Sterilization


[10705034036496]

Moist Heat or Steam Sterilization


[10705034036496]

Moist Heat or Steam Sterilization


[10705034036496]

Moist Heat or Steam Sterilization


[10705034036496]

Moist Heat or Steam Sterilization


[10705034036496]

Moist Heat or Steam Sterilization


[10705034036496]

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

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10705034338170 - N/A2025-05-21 MODIFIED INSTRUMENT ROD TEMPLATE, TRIAL 3.5 X 200mm
10705034577456 - N/A2025-05-14 INSERTION SLEEVE, STANDARD
10705034577463 - N/A2025-05-14 HEX ADAPTER
10705034577470 - N/A2025-05-14 INSERTION SLEEVE, SHORT
10705034577395 - N/A2025-05-07 ALIGNMENT GUIDE, FAS
10705034577401 - N/A2025-05-07 ALIGNMENT GUIDE, STANDARD

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