AccessGUDID - DEVICE: Cadwell Guardian (00840067103609)

GUDID

Device Identifier (DI) Information

Brand Name: Cadwell Guardian
Version or Model: 190316-200
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CADWELL INDUSTRIES, INC.

Primary DI Number: 00840067103609
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 098554157 *Terms of Use

Device Description: AVX Auditory and Visual Stimulator

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?
46566	Neurophysiologic monitoring system	An assembly of mains electricity (AC-powered) devices designed to monitor and provide electrical stimuli to spinal nerves or other neural pathways (may include the brain) during intraoperative surgery or intensive care, typically to reduce the incidence of accidental injury during instrumented spine surgery, or to diagnose acute dysfunction in corticospinal conduction (e.g., due to traction, shearing, laceration, compression, or vascular insufficiency). It typically displays electroencephalogram (EEG), electromyogram (EMG), and/or evoked responses. It typically includes an electric current pulse generator, electrodes and/or probes, and audible and/or visual indicators.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JXE	DEVICE, NERVE CONDUCTION VELOCITY MEASUREMENT
GWQ	Full-montage Standard Electroencephalograph
GWF	Stimulator, electrical, evoked response
GZO	Device, galvanic skin response measurement
OLT	Non-normalizing quantitative electroencephalograph software
PDQ	Neurosurgical nerve locator
GWE	Stimulator, photic, evoked response
GWJ	STIMULATOR, AUDITORY, EVOKED RESPONSE
IKN	Electromyograph, diagnostic
ETN	STIMULATOR, NERVE

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: 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: 1a7700dd-15b3-4341-99a0-a576759bb840
Public Version Date: May 22, 2024
Public Version Number: 2
DI Record Publish Date: March 04, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(509)735-6481
Email: applications@cadwell.com

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