Y-TEC® FS-300/A

GUDID 00884450170120

Merit Medical Systems, Inc.

Rigid optical laparoscope

• Primary Device ID: 00884450170120
• NIH Device Record Key: ca3ebe17-626f-41a7-b5f5-4cd8bdf09458
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Y-TEC®
• Version Model Number: 00884450170120
• Catalog Number: FS-300/A
• Company DUNS: 184763290
• Company Name: Merit Medical Systems, Inc.
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450170120 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K823295

FDA Product Code

• HET: LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-10

On-Brand Devices [Y-TEC®]

• 00884450260609: 00884450260609
• 00884450248119: 00884450248119
• 00884450170144: 00884450170144
• 00884450170120: 00884450170120