AccessGUDID - DEVICE: AURA (G460SP1010)

GUDID

Device Identifier (DI) Information

Brand Name: AURA
Version or Model: SP101
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: SP101
Company Name: Branchpoint & Aura Development LLC

Primary DI Number: G460SP1010
Issuing Agency: HIBCC
Commercial Distribution End Date: February 28, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 063237649 *Terms of Use

Device Description: AURA™ Sensor Tray

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 [?]
K172209	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
Storage Environment Humidity: between 20 and 85 Percent (%) Relative Humidity
Storage Environment Temperature: between 0 and 50 Degrees Celsius
Storage Environment Atmospheric Pressure: between 50 and 105 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 336c2897-155e-43ae-b0ea-2606f19430c9
Public Version Date: February 29, 2024
Public Version Number: 2
DI Record Publish Date: January 09, 2024