AccessGUDID - DEVICE: CarboClear Pedicle Screw System (07290110208509)

GUDID

Device Identifier (DI) Information

Brand Name: CarboClear Pedicle Screw System
Version or Model: Navigated Tap 5.0mm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PPS922760N
Company Name: CARBOFIX ORTHOPEDICS LTD

Primary DI Number: 07290110208509
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 649185170 *Terms of Use

Device Description: Navigated Bone Tap for use with the CarboClear Pedicle Screw System, designed for use with the Medtronic StealthStation® Navigation System.

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?
17507	Bone tap, reusable	A surgical instrument designed for cutting internal threads into bone, so that the threads facilitate the insertion of bone screws (not included). The screws may be used to anchor bone fragments, fixtures and/or other devices to the bone. It is typically manually rotated and consists of a metal shaft with a helical thread which may be cannulated or intersected with longitudinal cutting grooves. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NKB	Thoracolumbosacral Pedicle Screw System
OLO	Orthopedic Stereotaxic Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K201251	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
Outer Diameter: 5.0 Millimeter

Device Record Status

Public Device Record Key: cfc6fd03-11b1-4551-9ddb-747485f0afef
Public Version Date: December 08, 2022
Public Version Number: 2
DI Record Publish Date: August 09, 2020