AccessGUDID - DEVICE: Right Angle Guide (10381780034438)

GUDID

Device Identifier (DI) Information

Brand Name: Right Angle Guide
Version or Model: 991002
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 991002
Company Name: INTEGRA NEUROSCIENCES IMPLANT (FRANCE)

Primary DI Number: 10381780034438
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 531408342 *Terms of Use

Device Description: The Right Angle Guide is a component of Integra NeuroSciences Hydrocephalus Valve Systems. It is used to form a right angle bend in a F7, F8 ventricular catheter at the burr hole (diameter 5 mm). Implanted materials are silicone elastomer impregnated with barium sulfate.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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":	Yes
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?
61111	Intracranial catheter holder	A small, sterile device designed to secure an intracranial catheter (e.g., intracerebral sensor catheter, intracerebral infusion/drainage catheter, epidural sensor catheter) to the skin; it may also be used as a marker for the planned depth of the catheter insertion. It typically has a gripping mechanism which creates a right angle bend in the tube, and is intended to be held in place with sutures. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JXG	Shunt, central nervous system and components

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K913842	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
Device Size Text, specify: 4.9mm Diam.

Device Record Status

Public Device Record Key: cdae2687-1378-47f2-bb74-c2041d2d6f74
Public Version Date: February 17, 2023
Public Version Number: 4
DI Record Publish Date: October 01, 2015