Surgical irrigator

GUDID 10803622128117

LIVANOVA USA, INC.

Surgical fluid/gas irrigator

• Primary Device ID: 10803622128117
• NIH Device Record Key: bc3c85a5-66b5-4346-9f30-2f812cf06c9e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Surgical irrigator
• Version Model Number: MT-xxxxx
• Company DUNS: 080914995
• Company Name: LIVANOVA USA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00803622128110 [Primary]
GS1	10803622128117 [Package]; Contains: 00803622128110; Package: CASE [1 Units]; In Commercial Distribution

FDA Product Code

• FQH: LAVAGE, JET

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: 2018-08-15
• Device Publish Date: 2015-09-17

On-Brand Devices [Surgical irrigator]

• 10803622128117: MT-xxxxx
• 10803622106641: MT-xxxxx
• 10803622104081: MT-xxxxx
• 10803622104074: MT-xxxxx
• 10803622104067: MT-xxxxx