AccessGUDID - DEVICE: CAMINO® (10381780023630)

GUDID

Device Identifier (DI) Information

Brand Name: CAMINO®
Version or Model: 110-4BT
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 110-4BT
Company Name: INTEGRA LIFESCIENCES CORPORATION

Primary DI Number: 10381780023630
Issuing Agency: GS1
Commercial Distribution End Date: September 07, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 004729955 *Terms of Use

Device Description: INTRACRANIAL PRESSURE-TEMPERATURE MONITORING KIT

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:	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?
61398	Intracerebral sensor catheter, short-term	A flexible tube with a sensor at the distal end intended to be surgically inserted through the skull for short-term (= 30 days) access to the ventricular and/or parenchymal areas of the brain to measure intracranial parameters [e.g., intracranial pressure (ICP), temperature, partial pressure of oxygen (pO2)]; it may in addition be intended for cerebrospinal fluid (CSF) drainage and/or infusion of materials (e.g., chemotherapeutic agents, radioisotopes). It may include accessory devices intended to facilitate catheter introduction, stabilization, and/or fluid collection/infusion (e.g., stylet, bolts, drills, drainage/infusion port/reservoir). This is a single-use 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 [?]
Premarket Submission Number Not Available/Not Released

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
Device Size Text, specify: 0.106 in. (2.71 mm) diameter number 36 Drill Bit with safety stop; 0.050 in. (1.3 mm) diameter Stylet; 4 Fr (1.35 mm diameter) transducer tipped catheter

Device Record Status

Public Device Record Key: ade5f1c5-6a58-45c6-98f4-18c25778275c
Public Version Date: December 06, 2023
Public Version Number: 5
DI Record Publish Date: February 12, 2017