AccessGUDID - DEVICE: Licox® (10381780041412)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: 10381780041412
Issuing Agency: GS1
Commercial Distribution End Date: May 29, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 315902197 *Terms of Use

Device Description: Licox® PMOBOX Test Set

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:	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?
36798	Transistor tester	An electronic instrument designed to test the electrical performance of transistors and solid-state diodes to provide verification of their ability to function. It is typically used by biomedical service personnel involved in the repair, servicing, and maintenance of electrical medical devices. It is intended to be used by a healthcare provider (i.e., clinical technician) in a clinical setting.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K040235	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: 250 mm x 180 mm

Device Record Status

Public Device Record Key: 546108da-0ec7-41a6-825c-40771c74e36a
Public Version Date: June 10, 2020
Public Version Number: 4
DI Record Publish Date: October 09, 2017