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NuDEL

FDA UDI

Class III (US FDA UDI)

by B Braun Interventional Systems, Inc

Identity

Trade Name
NuDEL FDA UDI
Generic Name
Descending thoracic aorta endovascular stent-graft FDA UDI
Device Name
DEL002 NUDEL STENT DELSYS 1.6 14 2.5 12F FDA UDI
Model / Reference
614561 FDA UDI
Description
DEL002 NUDEL STENT DELSYS 1.6 14 2.5 12F FDA UDI

Identifiers

Catalog Number
614561 FDA UDI
Primary DI / UDI-DI
04046955218448 FDA UDI
PMA Number
P150028 FDA UDI
FDA Product Code
PNF FDA UDI
GMDN Term
Descending thoracic aorta endovascular stent-graft FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Descending thoracic aorta endovascular stent-graft

NuDEL by B Braun Interventional Systems, Inc — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Descending thoracic aorta endovascular stent-graft.

Cleared under the same submission

P150028 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
B Braun Interventional Systems, Inc

Sources (1)

  • FDA UDI 2c59d259-a687-4c02-b84a-a208e9b2b179 37 fields · synced May 31, 2026