KyphoFlex™ KPA20A

GUDID 10884450845315

Merit Medical Systems, Inc.

Inflatable bone tamp

• Primary Device ID: 10884450845315
• NIH Device Record Key: 400cba3d-eda8-4eb5-aae4-7b04bfb4c8e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KyphoFlex™
• Version Model Number: Initial Release
• Catalog Number: KPA20A
• 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: true
• 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	00884450845318 [Primary]
GS1	10884450845315 [Package]; Contains: 00884450845318; Package: [15 Units]; In Commercial Distribution

FDA Product Code

• HRX: Arthroscope

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: 2024-11-04
• Device Publish Date: 2024-10-25

On-Brand Devices [KyphoFlex™]

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