Outake® CET200

GUDID 10884450052584

Merit Medical Systems, Inc.

Scalpel, single-use

• Primary Device ID: 10884450052584
• NIH Device Record Key: 1c2db07f-eb73-45b5-8fad-69bc6190ec39
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Outake®
• Version Model Number: 00884450052587
• Catalog Number: CET200
• Company DUNS: 603160040
• 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: true
• Device Combination Product: true
• 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	00884450052587 [Primary]
GS1	10884450052584 [Package]; Contains: 00884450052587; Package: [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063048

FDA Product Code

• ODY: Tunneled catheter remover

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-06
• Device Publish Date: 2017-02-09

On-Brand Devices [Outake®]

• 10884450052584: 00884450052587
• 10884450051334: 00884450051337
• 10884450045494: 00884450045497