AccessGUDID - DEVICE: Resident Expert Software Module (00873263008089)

GUDID

Device Identifier (DI) Information

Brand Name: Resident Expert Software Module
Version or Model: C0258-00808
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: C0258
Company Name: FHC, INC.

Primary DI Number: 00873263008089
Issuing Agency: GS1
Commercial Distribution End Date: August 04, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 108179458 *Terms of Use

Device Description: Guideline 4000™ Resident Expert Software Module, 1x

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?
32568	Neurological stereotactic surgery system	An assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during neurosurgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HAW	Neurological stereotaxic Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K092192	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: 8b286afa-fcb4-4e7c-9528-7c5c460b4d89
Public Version Date: August 05, 2020
Public Version Number: 2
DI Record Publish Date: March 28, 2020