AccessGUDID - DEVICE: CarboClear Lumbar Cage System (07290110206888)

GUDID

Device Identifier (DI) Information

Brand Name: CarboClear Lumbar Cage System
Version or Model: Implant Trial-10x27x8mm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CCLC02708
Company Name: CARBOFIX ORTHOPEDICS LTD

Primary DI Number: 07290110206888
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 lumbar intervertebral body fusion device (cage). 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.

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
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K193378	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: cf0c3d5d-425c-4753-8aec-1dc328d99c12
Public Version Date: June 05, 2020
Public Version Number: 1
DI Record Publish Date: May 28, 2020