AccessGUDID - DEVICE: CarboClear X Pedicle Screw System (07290117350874)

GUDID

Device Identifier (DI) Information

Brand Name: CarboClear X Pedicle Screw System
Version or Model: MIS Distractor/Compressor
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MIS021
Company Name: CARBOFIX ORTHOPEDICS LTD

Primary DI Number: 07290117350874
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 649185170 *Terms of Use

Device Description: Part of the CarboClear X Pedicle Screw System - MIS Supplemental Set.

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?
64479	Surgical implant handling forceps	A hand-held manual surgical instrument with blades designed to grasp and manipulate a surgical implant (excluding sutures) during implantation; it is not intended for use on tissues, is not a dental or ophthalmic device, and is not a dedicated tissue clip applier. It is made of metal materials and may have one of various designs (e.g., tweezers-, scissors-, alligator-like) whereby the blades are designed to be opened/closed to handle a variety of implantable devices (e.g., orthopaedic joint prosthesis, breast implant, surgical mesh). This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NKB	Thoracolumbosacral Pedicle Screw System
OLO	Orthopedic Stereotaxic Instrument
PML	Bone Cement, Posterior Screw Augmentation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K231280	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: dbffc8d8-4e18-44f0-8de1-b0ffaa1fa18a
Public Version Date: September 21, 2023
Public Version Number: 1
DI Record Publish Date: September 13, 2023