AccessGUDID - DEVICE: 360CAS (B432360CAS01090)

GUDID

Device Identifier (DI) Information

Brand Name: 360CAS
Version or Model: KIC-DND-0109
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: KICO KNEE INNOVATION COMPANY PTY LIMITED

Primary DI Number: B432360CAS01090
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 757918953 *Terms of Use

Device Description: Array 075

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
42895	Robotic surgical navigation system application software	An individual application software program or group of programs, routines and/or algorithms designed for use in association with a robotic surgical navigation system used in computer assisted surgery (CAS) so that this can function according to its intended purpose. This program can be permanently installed or exchanged as an upgrade. It may also be produced for installation in an off-the-shelf desktop or laptop computer.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OLO	Orthopedic Stereotaxic Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K223927	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: ddd88480-b659-4f7a-b0b6-e6cea00a2883
Public Version Date: October 30, 2023
Public Version Number: 1
DI Record Publish Date: October 20, 2023