DFINE®

GUDID 10884450296315

Merit Medical Systems, Inc.

Orthopaedic cement preparation/delivery kit

• Primary Device ID: 10884450296315
• NIH Device Record Key: 7a023ff9-ff00-4b33-b349-0bcccfb7c08f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DFINE®
• Version Model Number: 00884450296318
• 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450296318 [Primary]
GS1	10884450296315 [Package]; Contains: 00884450296318; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072496

FDA Product Code

• NDN: CEMENT, BONE, VERTEBROPLASTY

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: 2017-06-02

On-Brand Devices [DFINE®]

• 00884450374399: 00884450374399
• 00884450374382: 00884450374382
• 00884450374283: 00884450374283
• 10884450296537: 00884450296530
• 10884450296520: 00884450296523
• 10884450296407: 00884450296400
• 10884450296353: 00884450296356
• 10884450296315: 00884450296318
• 10884450296186: 00884450296189
• 10884450296179: 00884450296172
• 10884450296155: 00884450296158
• 10884450296124: 00884450296127
• 10884450296117: 00884450296110
• 10884450296100: 00884450296103
• 00884450374375: 00884450374375
• 10884450296438: 00884450296431
• 00884450374320: 00884450374320
• 10884450374303: 00884450374306