AccessGUDID - DEVICE: CarboClear Cervical Cage / VBR System (07290110208981)

GUDID

Device Identifier (DI) Information

Brand Name: CarboClear Cervical Cage / VBR System
Version or Model: Implant Trial H=6
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PL940410
Company Name: CARBOFIX ORTHOPEDICS LTD

Primary DI Number: 07290110208981
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 649185170 *Terms of Use

Device Description: A surgical tool for use with the Cervical Cage / VBR devices. The Implant Trial is intended for use before insertion of the implant into the intervertebral space, to assist in selection of correct implant dimensions and to verify implant position within the disc space, as applicable.

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:	No
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?
44788	Spinal implant trial	A copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ODP	Intervertebral Fusion Device With Bone Graft, Cervical
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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 8ac2b2cd-8035-4e3e-b338-1448cbb4ae8f
Public Version Date: September 26, 2023
Public Version Number: 1
DI Record Publish Date: September 18, 2023