AccessGUDID - DEVICE: Quantum MIS Cannulated System (00846468050535)

GUDID

Device Identifier (DI) Information

Brand Name: Quantum MIS Cannulated System
Version or Model: 51-STIM-1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 51-STIM-1
Company Name: Pioneer Surgical Technology, Inc.

Primary DI Number: 00846468050535
Issuing Agency: GS1
Commercial Distribution End Date: May 22, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 793384496 *Terms of Use

Device Description: Nerve Monitoring Cable

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?
36081	Nerve-function monitor	A mains electricity (AC-powered) bedside device designed to continuously assess the adequacy of the nerve function of a non-ambulatory patient who requires monitoring (e.g., as a result of trauma, anaesthesia, intervention, evaluation). It typically monitors evoked potential (EP), electromyography (EMG), electroencephalography (EEG) and/or neuromuscular block response. It typically consists of electrodes applied to the patient intended to acquire the neural electrical signal, and a computerized unit to process and display the information; stimulation systems for nerve block and evoked potential evaluation are separate requirements.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ETN	STIMULATOR, NERVE
GXZ	ELECTRODE, NEEDLE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: b3f68720-27b3-46d8-a516-7889b1f37660
Public Version Date: August 09, 2024
Public Version Number: 3
DI Record Publish Date: September 25, 2020