OS 11G BONE FILLER KIT-OSTEOFIX

GUDID 00815212026966

Izi Medical Products, LLC

Orthopaedic cement, non-antimicrobial

• Primary Device ID: 00815212026966
• NIH Device Record Key: 1e429272-e3a7-455b-adcc-3f2183cfc3ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OS 11G BONE FILLER KIT-OSTEOFIX
• Version Model Number: G80012
• Company DUNS: 933506164
• Company Name: Izi Medical Products, LLC
• 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: true
• 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	00815212026966 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103433

FDA Product Code

• NDN: Cement, Bone, Vertebroplasty

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: 2025-04-03
• Device Publish Date: 2025-03-26

Devices Manufactured by Izi Medical Products, LLC

• 00815212026966 - OS 11G BONE FILLER KIT-OSTEOFIX: 2025-04-03
• 00815212026966 - OS 11G BONE FILLER KIT-OSTEOFIX: 2025-04-03
• 00815212026942 - BKP-10-12.0-15.0-B: 2025-01-16
• 00815212026959 - BKP-11-12.0-15.0-B: 2025-01-16
• 00815212026935 - Duro-Ject Bone Cement Injection Tube: 2024-10-22
• 00815212026911 - KIT:BALLOON AND BONE FILLER: 2024-09-05
• 00815212026928 - KIT:BALLOON,FILLER,ACCESS,DRILL: 2024-09-05
• 10815212026895 - OsteoPearl Vertebral Balloon (15mm), 10G: 2024-08-13
• 00815212026904 - OsteoPearl Vertebral Balloon (15mm) & Inflation Device Kit, 10G: 2024-08-13