NuDEL

Basic Information

• Brand Name: NuDEL
• Primary DI: 04046955218455
• Version / Model: 614562
• Catalog Number: 614562
• Company Name: B BRAUN INTERVENTIONAL SYSTEMS, INC
• Labeler DUNS: 784259751
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-04-14
• Public Version: 6
• Public Version Date: 2023-09-07
• Public Version Status: Update
• Public Device Record Key: 69f4ae6f-972e-470b-b734-041c69e21b85

Device Description

DEL003 NUDEL STENT DELSYS 1.6 16 2.5 12F

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
PNF	Aortic stent	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
43583	General aorta endovascular stent-graft	A non-bioabsorbable tubular device intended to be implanted in a non-specific region of the aorta to maintain aortic patency and improve luminal diameter in patients with symptomatic atherosclerotic disease or recurrent coarctation (narrowing) of the aorta. It is a mesh structure made of metal (e.g., platinum, iridium) that is covered with a synthetic polymer [e.g., polytetrafluoroethylene (ePTFE)] membrane (endovascular graft). It is typically expanded in situ (e.g., balloon-expandable) and 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	04046955218455	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P150028	000
P150028	002

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: KEEP AWAY FROM SUNLIGHT
• Type: Storage Environment Temperature
• Temperature Range: 4 – 45 Degrees Celsius
• Type: Special Storage Condition, Specify