AccessGUDID - DEVICE: CarboClear Cervical Systems (07290110207229)

GUDID

Device Identifier (DI) Information

Brand Name: CarboClear Cervical Systems
Version or Model: Cervical Caliper
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PL940230
Company Name: CARBOFIX ORTHOPEDICS LTD

Primary DI Number: 07290110207229
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 649185170 *Terms of Use

Device Description: Intended to assist in determining the required implant length during operation.

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?
35788	Orthopaedic bone calliper	A hand-held manual surgical instrument consisting of two legs hinged at one end designed to measure various bone dimensions (e.g., diameter or length) required for orthopaedic procedures. It has an attached scale to indicate the measured units. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ODP	Intervertebral Fusion Device With Bone Graft, Cervical
PLR	Spinal Vertebral Body Replacement Device - Cervical
KWQ	Appliance, Fixation, Spinal Intervertebral Body

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K200883	000
K222874	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: 9776d209-6321-4b67-8988-7f0b079268d6
Public Version Date: September 19, 2023
Public Version Number: 2
DI Record Publish Date: June 09, 2020