AccessGUDID - DEVICE: XactTrode Patient Cable (00814901021312)

GUDID

Device Identifier (DI) Information

Brand Name: XactTrode Patient Cable
Version or Model: 029453
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 029453
Company Name: BLACKROCK MICROSYSTEMS, LLC

Primary DI Number: 00814901021312
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 827132015 *Terms of Use

Device Description: XactTrode Patient Cable, 96 Contact with Quantum Connector, 10ft

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
36740	Electroencephalographic signal amplifier	An electrical device intended to amplify the signal level and to provide impedance matching between two or more medical devices when bioelectrical signals from the brain are transmitted between them.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IKD	Cable, Electrode

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K191346	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Ethylene Oxide
Hydrogen Peroxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 10 Feet

Device Record Status

Public Device Record Key: e8fbfd00-f279-4a6a-9880-779dd58c7038
Public Version Date: November 28, 2022
Public Version Number: 2
DI Record Publish Date: February 05, 2021