AccessGUDID - DEVICE: CarboClear Cervical VBR System (07290110209018)

GUDID

Device Identifier (DI) Information

Brand Name: CarboClear Cervical VBR System
Version or Model: VBR Spacer
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CVBR14160
Company Name: CARBOFIX ORTHOPEDICS LTD

Primary DI Number: 07290110209018
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 649185170 *Terms of Use

Device Description: A cervical spine vertebral body replacement device

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):	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?
34170	Vertebral body prosthesis	An implantable device designed to replace one or more vertebral body(s) that has collapsed or been surgically removed due to trauma, tumour or degenerative disease. Also known as a corpectomy or vertebrectomy spacer, it is in the form of a one-piece or modular hollow cylinder made of inorganic materials (e.g., metal, polymer). It is typically used with supplemental spinal fixation and/or bone graft, and some types are adjustable for in situ adjustment of prosthesis height to allow intraoperative distraction of adjacent vertebrae.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
PLR	Spinal Vertebral Body Replacement Device - Cervical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K222874	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
Height: 16 Millimeter
Width: 14 Millimeter
Depth: 12 Millimeter
Angle: 0 degree

Device Record Status

Public Device Record Key: ae97a1fb-8c92-433f-93b7-ef69dc49b4ad
Public Version Date: October 10, 2023
Public Version Number: 1
DI Record Publish Date: October 02, 2023