AccessGUDID - DEVICE: Cyst Puncture Catheter (10381780034285)

GUDID

Device Identifier (DI) Information

Brand Name: Cyst Puncture Catheter
Version or Model: 951401
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 951401
Company Name: INTEGRA NEUROSCIENCES IMPLANT (FRANCE)

Primary DI Number: 10381780034285
Issuing Agency: GS1
Commercial Distribution End Date: May 18, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 531408342 *Terms of Use

Device Description: The Cyst Puncture Catheter is a 25 cm long, radiopaque silicone elastomer catheter with a tapered end terminating in a tip with a hole. The catheter features radiopaque length markings at 5, 10 and 15 cm from the tip. The catheter has 2 drainage holes, 180 degrees apart, located 5 mm from the tip. The proximity of the holes near the tip ensures that the holes will not extend outside small cysts. Each catheter is supplied with 2 stylets: a blunt-ended stylet and a sharp-ended stylet.

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":	Yes
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?
61376	Intracerebral infusion/drainage catheter, long-term	A sterile, flexible tube intended to be surgically inserted through the skull for long-term (> 30 days) subdural access to the brain (e.g., cerebral ventricles, cystic tumours) for cerebrospinal fluid (CSF) drainage and/or infusion of materials (e.g., chemotherapeutic agents); it is typically used for measurement of intracranial pressure (ICP) and as part of a shunt system. It may include an attached port/reservoir at its proximal end that is placed subcutaneously to facilitate material infusion/collection, and/or accessory devices intended to facilitate catheter introduction and/or stabilization (e.g., stylet, catheter holder); it does not include a sensor. This is a single-use device.	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 [?]
K955265	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: 25cm Length x 2.7mm O.D. x 1.4mm I.D. (F8)

Device Record Status

Public Device Record Key: 5a83b893-b562-479b-b9bd-02e2fb1fac6a
Public Version Date: May 18, 2021
Public Version Number: 5
DI Record Publish Date: October 01, 2015