Faller Trocar FT-1100/A

GUDID 10884450169992

Merit Medical Systems, Inc.

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• Primary Device ID: 10884450169992
• NIH Device Record Key: 01be8b04-ed45-46fe-93b8-d58ecea0eae1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Faller Trocar
• Version Model Number: 00884450169995
• Catalog Number: FT-1100/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: true
• 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	00884450169995 [Primary]
GS1	10884450169992 [Package]; Contains: 00884450169995; Package: [1 Units]; In Commercial Distribution
GS1	20884450169999 [Package]; Package: [58 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120130

FDA Product Code

• FJS: CATHETER, PERITONEAL, LONG-TERM INDWELLING

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: 2015-10-30

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