AccessGUDID - DEVICE: Integra® (10381780037071)

GUDID

Device Identifier (DI) Information

Brand Name: Integra®
Version or Model: EDSCF
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: INTEGRA NEUROSCIENCES IMPLANT (FRANCE)

Primary DI Number: 10381780037071
Issuing Agency: GS1
Commercial Distribution End Date: September 24, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 531408342 *Terms of Use

Device Description: The electrode connecting cable EDSCF is a reusable device used to connect the Integra® Sphenoidal electrodes intended for the recording of EEG signals at the under surface of the temporal lobe, to an EEG monitor. The cable features gold-plated electrodes contact pin at one end and monitor connector contacts on the other end.

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":	Yes
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?
35749	Analytical scalp lead	A wire(s) intended to connect an electroencephalographic electrode(s) to an electroencephalographic system to facilitate the transmission of the electrical signals captured at the site of the electrode to the system for measuring, recording, monitoring and/or analysis during encephalography (EEG); the electrodes are not included. The procedure is performed to record, monitor, and/or analyse the brain's electrical activity. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IKD	CABLE, ELECTRODE

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: STORE IN COOL DRY PLACE

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7d2aa017-ac9f-4b77-bb3c-bf9f2c4b0b94
Public Version Date: September 24, 2019
Public Version Number: 4
DI Record Publish Date: August 12, 2016