AccessGUDID - DEVICE: Licox® (10381780041283)

GUDID

Device Identifier (DI) Information

Brand Name: Licox®
Version or Model: BC10
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: BC10
Company Name: GMS, Gesellschaft für medizinische Sondentechnik mbH

Primary DI Number: 10381780041283
Issuing Agency: GS1
Commercial Distribution End Date: August 02, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 315902197 *Terms of Use

Device Description: Licox® Probe Cable Kit

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:	Yes
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?
47487	Electrical-only medical device connection cable, reusable	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. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GWM	DEVICE, MONITORING, INTRACRANIAL PRESSURE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K002765	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
Device Size Text, specify: 173 mm x 260 mm x 45 mm

Device Record Status

Public Device Record Key: 4c2e2af8-df1b-44df-bd61-bf22bce797d4
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 01, 2015