AccessGUDID - DEVICE: PreOp (05430000733021)

GUDID

Device Identifier (DI) Information

Brand Name: PreOp
Version or Model: v2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Clouds of Care

Primary DI Number: 05430000733021
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 371252830 *Terms of Use
Previous DI: 05430000733007

Device Description: PreOp is active medical device software (MSDW) intended for use by a trained Epilog EEG technologist / Operator in combination with Persyst EEG Review and Analysis Software on both adult and pediatric subjects at least 3 years of age for 3D visualization of the human brain function recorded with EEG and using a patient-specific MR image.

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?
47541	Bioelectrical signal analysis software	A software program intended to acquire, process, store and analyse biological electrical signals, both in real-time and delayed time, for diagnostic applications. The signals are typically provided by electrophysiological recording/monitoring [e.g., electromyography (EMG), electroencephalography (EEG), evoked potentials (EP), bioelectrical impedance analysis (BIA)]. It may be installed in the recording/monitoring device, personal computer, or data network server. It is neither intended for continuous bedside nor intraoperative monitoring, and is not dedicated to hearing analysis.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OLX	Source Localization Software For Electroencephalograph Or Magnetoencephalograph

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K172858	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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: 67abb55e-ed99-407c-b359-052b5822fe10
Public Version Date: June 29, 2023
Public Version Number: 2
DI Record Publish Date: June 22, 2022