KyphoFlex™ ACC-KK001

GUDID 00884450847046

Merit Medical Systems, Inc.

Vertebral body cement cannula

• Primary Device ID: 00884450847046
• NIH Device Record Key: 0cb71396-fbee-4330-85ef-2d008a715df3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KyphoFlex™
• Version Model Number: Initial Release
• Catalog Number: ACC-KK001
• Company DUNS: 184763290
• Company Name: Merit Medical Systems, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• OTC Over-The-Counter: false

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450847046 [Primary]

FDA Product Code

• MDM: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-17
• Device Publish Date: 2024-10-09

On-Brand Devices [KyphoFlex™]

• 00884450847046: Initial Release
• 10884450845322: Initial Release
• 10884450845315: Initial Release
• 10884450845308: Initial Release