AccessGUDID - DEVICE: Atrial Catheter (10381780034292)

GUDID

Device Identifier (DI) Information

Brand Name: Atrial Catheter
Version or Model: 953100
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 953100
Company Name: INTEGRA NEUROSCIENCES IMPLANT (FRANCE)

Primary DI Number: 10381780034292
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 Atrial Catheter is used to drain cerebrospinal fluid from the outlet of the valve unit into the right atrium of the heart. The distal end of the catheter does not have any slits.

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":	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?
61159	Peritoneal/atrial cerebrospinal fluid catheter	A flexible tube intended to be implanted as the distal component of a ventriculo-peritoneal/atrial shunt, to channel cerebrospinal fluid (CSF) to either the peritoneal cavity or the right atrium (i.e., dual-capability) where it can be absorbed into the body. It is intended to be part of a therapeutic measure for situations where excess CSF causes elevated intracranial pressure (hydrocephalus). Disposable devices associated with implantation may be included.	Active	true

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K861377	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: 46cm Length x 2.3mm O.D. x 1.1mm I.D. (F7)

Device Record Status

Public Device Record Key: 36373d46-643a-47e0-a205-1a06e4ab41b0
Public Version Date: February 09, 2023
Public Version Number: 6
DI Record Publish Date: October 01, 2015