AccessGUDID - DEVICE: BIOPSYBELL SRL (08033860037499)

GUDID

Device Identifier (DI) Information

Brand Name: BIOPSYBELL SRL
Version or Model: VERTEMAX KYPHOPLASTY TOOLS KIT
Commercial Distribution Status: In Commercial Distribution
Catalog Number: VMX-08UK
Company Name: BIOPSYBELL SRL

Primary DI Number: 08033860037499
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 438746708 *Terms of Use

Device Description: KYPHOPLASTY TOOL KIT

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?
58031	Bone access channel kit	A collection of sterile manual devices intended to create a percutaneous access channel within a vertebral body or other bones (e.g., hand, radius, tibia, calcaneus) prior to the use of an inflatable balloon (e.g., a balloon catheter or balloon tamp) to create a bone space during kyphoplasty/osteoplasty. It typically consists of bone access needles/cannulae, orthopaedic bone wires (Kirschner wires), a drill, and a curette. It is used in orthopaedic surgery, typically under fluoroscopic guidance, to treat a patient diagnosed with compression fractures. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OCJ	Spinal Channeling Instrument, Vertebroplasty

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 08 Gauge

Device Record Status

Public Device Record Key: 949e4984-b957-4409-b0c5-195a79647993
Public Version Date: June 21, 2023
Public Version Number: 1
DI Record Publish Date: June 13, 2023