AccessGUDID - DEVICE: Dorado KT Cart with Evox (240V) (00627825005296)

GUDID

Device Identifier (DI) Information

Brand Name: Dorado KT Cart with Evox (240V)
Version or Model: Dorado KT with EVOX
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Laborie Medical Technologies Canada ULC

Primary DI Number: 00627825005296
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 203383526 *Terms of Use

Device Description: No description.

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):	No
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?
11614	Evoked-potential graphic recording system	An assembly of devices designed for recording a localized electrical potential from the brain or spinal cord in response to stimulation (i.e., visual, auditory, and/or somatosensory) of the sensory organs, or of some point along the ascending pathway from the sensory organs, or within the central nervous system. It typically includes a sensory stimulator/stimulation system and a graphic recorder. The characteristics of the recorded potential vary with recording location, stimulus modality and level, and level of consciousness or anaesthesia. The resultant waveform may be used to assess the function and integrity of the brain and its sensory pathways.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JXE	DEVICE, NERVE CONDUCTION VELOCITY MEASUREMENT
GWF	STIMULATOR, ELECTRICAL, EVOKED RESPONSE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K082614	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: c2e39c20-8e75-4367-909d-a55528c1a4f2
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 21, 2016