Infiltration Handle with Luer Lock Fitting INF-HAN-L

GUDID 00081317020073

Infiltration Handle with Luer Lock Fitting

MENTOR TEXAS L.P.

Surgical irrigation/aspiration tubing set

• Primary Device ID: 00081317020073
• NIH Device Record Key: 5c26baaa-dd95-49bc-aa7d-332a5ec7ebed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Infiltration Handle with Luer Lock Fitting
• Version Model Number: INF-HAN-L
• Catalog Number: INF-HAN-L
• 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: false
• 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)235-5731
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00081317020073 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K981172

FDA Product Code

• MUU: System, suction, lipoplasty

Sterilization

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

[00081317020073]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-04-23
• Device Publish Date: 2016-09-23

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