AccessGUDID - DEVICE: CarboClear X Pedicle Screw System (07290117350904)

GUDID

Device Identifier (DI) Information

Brand Name: CarboClear X Pedicle Screw System
Version or Model: MIS Sterilization Box
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MIS101
Company Name: CARBOFIX ORTHOPEDICS LTD

Primary DI Number: 07290117350904
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 649185170 *Terms of Use

Device Description: Sterilization Box for use with 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?
42997	Surgical instrument/implant rack	A device designed as a small case, typically with a hinged lid that can be closed to protect the contents (i.e., surgical instruments and/or implantable devices such as plates or screws), and an integral rest(s) with grooves or notches in the upper edge so that the contents can be securely placed, protected, and organized. The lid or rest may be set at an angle to facilitate instrument/implant access during surgical procedures or sterilization. The device is typically be made of stainless steel or a suitable plastic material so that it can be sterilized. This is a reusable device.	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: 7e3961a0-e0c1-4301-8513-bc070ad27a49
Public Version Date: September 05, 2023
Public Version Number: 1
DI Record Publish Date: August 28, 2023