AccessGUDID - DEVICE: Compumedics Quik-Cap (09342451004635)

GUDID

Device Identifier (DI) Information

Brand Name: Compumedics Quik-Cap
Version or Model: Quik-Cap Neoprene Flexnet - Grael 64 Ch Small
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8035-0029-01
Company Name: COMPUMEDICS LIMITED

Primary DI Number: 09342451004635
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 753750967 *Terms of Use

Device Description: Quik-Cap Neoprene Flexnet - Grael 64 Ch Small

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?
17554	Electroencephalographic electrode cap, single-use	An array of analytical scalp electrodes preconfigured within a head-worn device designed for the rapid placement and appropriate positioning of the scalp electrodes during electroencephalography (EEG). It typically consists of a cap-like device with integrated scalp electrodes, and shielded lead wires that terminate into a connector that mates with a separate cable. The device eliminates the need to glue or paste individual electrodes to the patient’s scalp. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GXY	Electrode, Cutaneous

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K000865	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: ae986116-f5e7-40db-85f4-f6a872e77bec
Public Version Date: March 10, 2026
Public Version Number: 1
DI Record Publish Date: March 02, 2026