AccessGUDID - DEVICE: CarboClear Cervical Plate System (07290110207168)

GUDID

Device Identifier (DI) Information

Brand Name: CarboClear Cervical Plate System
Version or Model: Cervical Plate Awl
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PL940260
Company Name: CARBOFIX ORTHOPEDICS LTD

Primary DI Number: 07290110207168
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 649185170 *Terms of Use

Device Description: Used to gain access through the bone cortex.

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?
15275	Bone awl, reusable	A spike-like, manual, orthopaedic surgical instrument intended to bore holes in bone. It is a straight or slightly curve rod-like instrument with a sharp, trocar-like point at the distal end and a T-shaped handle at the proximal end, typically made of metallic and/or synthetic material. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KWQ	Appliance, Fixation, Spinal Intervertebral Body

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K200883	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: 88d5b01c-b0fd-4691-be13-1067a1595ead
Public Version Date: June 10, 2022
Public Version Number: 2
DI Record Publish Date: June 09, 2020