AccessGUDID - DEVICE: EZ-Track (00840314133045)

GUDID

Device Identifier (DI) Information

Brand Name: EZ-Track
Version or Model: CAFB552415H
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CAFB552415H
Company Name: NEXT ORTHOSURGICAL, INC.

Primary DI Number: 00840314133045
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 046767258 *Terms of Use

Device Description: LLIF INTERBODY CAGE, 24 X 55 X 15MM -7°

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:	Yes
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?
60458	Visual input/output switching adaptor	A mains electricity (AC-powered) device intended to be used to manage the distribution of four digital visual interface (DVI) video sources to four DVI peripheral devices. It is typically used during endoscopic, microsurgical or open surgical procedures in an operating room (OR) or clinic to switch DVI-D (DVI-digital) compatible video signals from video capture sources (e.g., endoscope-/microscope-cameras, multi-purpose digital medical camera, surgical video camera, ultrasonic devices) to output devices (e.g., monitors, transmitters or encoding devices).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K131082	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
Width: 24 Millimeter
Length: 55 Millimeter
Height: 15 Millimeter
Angle: 7 degree

Device Record Status

Public Device Record Key: dc7a2677-f086-4ee7-9298-0c984b018f46
Public Version Date: September 19, 2024
Public Version Number: 1
DI Record Publish Date: September 11, 2024