AccessGUDID - DEVICE: Integra® (10381780024309)

GUDID

Device Identifier (DI) Information

Brand Name: Integra®
Version or Model: NL8501376
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NL8501376
Company Name: Integra Lifesciences Corporation

Primary DI Number: 10381780024309
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 083171244 *Terms of Use

Device Description: Integra® Peritoneal Open-Ended Catheter With Slits Peritoneal Open-Ended Catheter with Slits Barium Impregnated Stripe

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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 [?]
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: Tubing: 1.3mm I.D. x 2.5mm O.D.; Total Length: 120cm (47 1/4") (All dimensions nominal)

Device Record Status

Public Device Record Key: 68c53414-8943-4f82-876e-5f84b9b7deab
Public Version Date: May 16, 2023
Public Version Number: 6
DI Record Publish Date: December 15, 2016