MENTOR CENTERSCOPE Magnetic Detection Device 350-4402

GUDID 00081317004042

MENTOR TEXAS L.P.

Tissue expander injection port locator

• Primary Device ID: 00081317004042
• NIH Device Record Key: dd244a7f-f7b8-4f80-b58c-627419f9294d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MENTOR CENTERSCOPE Magnetic Detection Device
• Version Model Number: 350-4402
• Catalog Number: 350-4402
• Company DUNS: 167450993
• Company Name: MENTOR TEXAS L.P.
• 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: true
• 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)235-5731
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00081317004042 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011500

FDA Product Code

• LCJ: EXPANDER, SKIN, INFLATABLE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-21

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