Integra®

Basic Information

• Brand Name: Integra®
• Primary DI: 10381780024255
• Version / Model: NL8501220
• Catalog Number: NL8501220
• Company Name: Integra Lifesciences Corporation
• Labeler DUNS: 083171244
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-15
• Public Version: 6
• Public Version Date: 2023-05-16
• Public Version Status: Update
• Public Device Record Key: 0d9792db-8c8a-47a7-b87d-50d986e93a34

Device Description

Integra® Pudenz Infant Cardiac Catheter Barium Impregnated Barium Stripe

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JXG	Shunt, central nervous system and components	Neurology	882.5550	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61158	Atrial cerebrospinal fluid catheter	A flexible tube intended to be implanted as the distal component of a ventriculoatrial shunt to channel cerebrospinal fluid (CSF) to the right atrium where it can be absorbed into the body. It is intended to be part of a therapeutic measure for situations where increased CSF causes elevated intracranial pressure (hydrocephalus). Disposable devices associated with implantation may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10381780024255	GS1
Secondary	M269NL85012201	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Distal Tubing: 0.7 mm ID x 1.3 mm OD; Distal Tube Length: 9 cm; Proximal Tubing: 1.3 mm ID x 2.2mm OD; Total Length: 55 cm (22") (All dimensions nominal)

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: SpeciaAvoid contaminants such as lint, fingerprints, or talc.