AccessGUDID - DEVICE: KIVA ULTRAFLEX CEMENT NEEDLE KIT (00815212023590)

GUDID

Device Identifier (DI) Information

Brand Name: KIVA ULTRAFLEX CEMENT NEEDLE KIT
Version or Model: ACC5350
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Izi Medical Products, LLC

Primary DI Number: 00815212023590
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 933506164 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LOD	Bone Cement

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K141141	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 39727868-adf4-4e49-80fd-761a1263f4ac
Public Version Date: October 25, 2021
Public Version Number: 1
DI Record Publish Date: October 15, 2021