BKP-11-12.0-15.0

GUDID 00815212026768

Izi Medical Products, LLC

Balloon kyphoplasty kit

• Primary Device ID: 00815212026768
• NIH Device Record Key: 3694600e-7563-46f7-b5f2-2a0896fb6f0a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BKP-11-12.0-15.0
• Version Model Number: G11015
• Company DUNS: 933506164
• Company Name: Izi Medical Products, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815212024399 [Package]; Package: [1 Units]; In Commercial Distribution
GS1	00815212026768 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200763

FDA Product Code

• NDN: Cement, Bone, Vertebroplasty

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-10-02
• Device Publish Date: 2020-08-26

On-Brand Devices [BKP-11-12.0-15.0]

• 00815212024399: G11015
• 00815212026768: G11015