AccessGUDID - DEVICE: CarboClear X Pedicle Screw System (07290117350812)

GUDID

Device Identifier (DI) Information

Brand Name: CarboClear X Pedicle Screw System
Version or Model: MIS Rod Inserter
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MIS010
Company Name: CARBOFIX ORTHOPEDICS LTD

Primary DI Number: 07290117350812
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?
12696	Orthopaedic inorganic implant inserter/extractor, reusable	A hand-held manual surgical instrument designed for the surgical insertion and/or extraction of a non-tissue based (inorganic) orthopaedic implant (e.g., a bone nail, spiral blade, or bone fixation plate). It is an instrument in a one-piece or modular configuration with a region that will attach/fit/lock to part of the implant, and typically features either a mechanism to apply a striking force (e.g., on a pad/flange) a mechanism for twisting (screwing) (e.g., T-handle), or a plunger mechanism to deploy a guide to drive the implant into place. 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: 32560335-cbf4-47ec-8193-bb3d1f26a6ab
Public Version Date: September 11, 2024
Public Version Number: 2
DI Record Publish Date: September 12, 2023