AccessGUDID - DEVICE: BIOPSYBELL (08033860024000)

GUDID

Device Identifier (DI) Information

Brand Name: BIOPSYBELL
Version or Model: RENOVA SPINE BALLOON CATHETER
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RESB20J
Company Name: BIOPSYBELL SRL

Primary DI Number: 08033860024000
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 438746708 *Terms of Use

Device Description: REDUCTION AND FIXATION OF FRACTURES AND/OR CREATION OF A VOID IN CANCELLOUS BONE IN THE SPINE DURING BALLOON KYPHOPLASTY (FOR USE WITH CLEARED SPINAL POLYMETHYLMETHACRYLATE (PMMA) BONE CEMENTS)

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
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?
58020	Kyphoplasty balloon catheter	A sterile, flexible tube designed to be used for the creation of a void within a vertebral body during a minimally invasive procedure commonly known as balloon kyphoplasty. It is manually inserted percutaneously through an access channel under fluoroscopic guidance to a vertebral compression fracture (VCF) site (e.g., in the lumbar or thoracic region of the spine) where its balloon is inflated with a medium (e.g., a liquid contrast medium) to force the vertebrae apart for insertion of bone cement; thereafter it is deflated and removed via the access channel. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HRX	Arthroscope
NDN	Cement, Bone, Vertebroplasty

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K231340	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
Needle Gauge: 11 Gauge
Balloon Length: 20 Millimeter

Device Record Status

Public Device Record Key: 3ae573a5-d765-4df3-9111-112060f7a27f
Public Version Date: January 21, 2025
Public Version Number: 2
DI Record Publish Date: January 11, 2024