AccessGUDID - DEVICE: Sterile electrode's cable (07290114061612)

GUDID

Device Identifier (DI) Information

Brand Name: Sterile electrode's cable
Version or Model: Sterile electrode's cable
Commercial Distribution Status: In Commercial Distribution
Catalog Number: STR-000526-55
Company Name: ALPHA OMEGA ENGINEERING CO. LTD.

Primary DI Number: 07290114061612
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 531856466 *Terms of Use

Device Description: No description.

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?
47143	Electrical-only medical device connection cable, single-use	A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. Some types may include an electrical isolator to prevent electrical shocks, and/or a cable cover. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GZL	Electrode, Depth

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K120098	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 88a42478-dcd3-4761-9517-df1999aeb66d
Public Version Date: May 22, 2023
Public Version Number: 1
DI Record Publish Date: May 12, 2023