KIVA INTRODUCER SET

Basic Information

• Brand Name: KIVA INTRODUCER SET
• Primary DI: 00815212023606
• Version / Model: ACC5270
• Company Name: Izi Medical Products, LLC
• Labeler DUNS: 933506164
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-10-15
• Public Version: 1
• Public Version Date: 2021-10-25
• Public Version Status: New
• Public Device Record Key: 4d271542-e405-40c8-8af4-f56281bcf4f8

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LOD	Bone Cement	Orthopedic	888.3027	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58159	Vertebral body cement-containing implant	A sterile implantable device designed as a small pouch for percutaneous insertion into a vertebral body and inflated through the injection of orthopaedic cement, intended to provide a bone filler container (BFC) that ensures leakage-free containment of the cement within the vertebral body to restore its height during vertebroplasty and kyphoplasty. It is typically made of a non-bioabsorbable, non-stretchable fabric; implantation instruments may be included. It is used in orthopaedic surgery, typically under fluoroscopic guidance, to treat patients diagnosed with vertebral compression fractures (VCFs) in the lumbar or thoracic region of the spine.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00815212023606	GS1

Premarket Submissions

Submission Number	Supplement Number
K141141	000