176016015

GUDID 10705034036205

SURGICAL TITANIUM MESH MESH, 16MM ROUND 15mm

DEPUY SPINE, LLC

Metallic spinal fusion cage, non-sterile

• Primary Device ID: 10705034036205
• NIH Device Record Key: da9caf5d-3160-42d5-b451-00140d52b7e1
• Commercial Distribution Discontinuation: 2019-04-30
• Commercial Distribution Status: Not in Commercial Distribution
• Version Model Number: 176016015
• Catalog Number: 176016015
• Company DUNS: 107105876
• Company Name: DEPUY SPINE, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034036205 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K900138

FDA Product Code

• EZX: Mesh, surgical, metal

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[10705034036205]

Moist Heat or Steam Sterilization

[10705034036205]

Moist Heat or Steam Sterilization

[10705034036205]

Moist Heat or Steam Sterilization

[10705034036205]

Moist Heat or Steam Sterilization

[10705034036205]

Moist Heat or Steam Sterilization

[10705034036205]

Moist Heat or Steam Sterilization

[10705034036205]

Moist Heat or Steam Sterilization

[10705034036205]

Moist Heat or Steam Sterilization

[10705034036205]

Moist Heat or Steam Sterilization

[10705034036205]

Moist Heat or Steam Sterilization

[10705034036205]

Moist Heat or Steam Sterilization

[10705034036205]

Moist Heat or Steam Sterilization

[10705034036205]

Moist Heat or Steam Sterilization

[10705034036205]

Moist Heat or Steam Sterilization

[10705034036205]

Moist Heat or Steam Sterilization

[10705034036205]

Moist Heat or Steam Sterilization

[10705034036205]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-04-30
• Device Publish Date: 2015-09-24

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• 10705034576688 - N/A: 2024-09-19 MODIFIED INSTRUMENT ACDF SHIM