AccessGUDID - DEVICE: CORTAC® (00650551101925)

GUDID

Device Identifier (DI) Information

Brand Name: CORTAC®
Version or Model: 2110TX-32-100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2110TX-32-100
Company Name: PMT CORPORATION

Primary DI Number: 00650551101925
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 039576871 *Terms of Use

Device Description: SUBDURAL GRID ELECTRODE, PLATINUM, 32 CONTACT, 4X8, CONTACT #1 RADIOPAQUE, TEXTURED, INLINE CONNECTOR, 2 EXITS, 2 LEADS, 2 TAILS, TOP & BOTTOM ROWS NUMBERED, CLOVERLEAF

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":	Yes
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?
32545	Cortical electrode	A sterile, invasive, electrical conductor that is temporarily placed (< 30 days) on the surface of the brain to stimulate the brain or to record the brain's electrical activity (with more precise localization than a scalp electrode). It is typically a series of discs mounted in thin plastic strips, or in a square/rectangular grid to cover larger surface areas. The implanted device, also known as a subdural electrode, is connected to recording, monitoring, or stimulation/response devices [e.g., electroencephalograph (EEG), evoked-potential recorder, stimulator]. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GYC	Electrode, Cortical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K082474	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 58 and 78 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Thickness 0.76 Millimeter
Device Size Text, specify: Contact Diameter 4.5 Millimeter

Device Record Status

Public Device Record Key: 54f85970-bd50-44ea-9144-9ab31392c45a
Public Version Date: December 03, 2018
Public Version Number: 1
DI Record Publish Date: October 31, 2018