DEVICE: NuDEL (04046955218691)
Device Identifier (DI) Information
NuDEL
614587
In Commercial Distribution
614587
B BRAUN INTERVENTIONAL SYSTEMS, INC
614587
In Commercial Distribution
614587
B BRAUN INTERVENTIONAL SYSTEMS, INC
DEL028 NUDEL STENT DELSYS 4.5 24 5 14F
Device Characteristics
MR Conditional | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
48060 | Descending thoracic aorta endovascular stent-graft |
A non-bioabsorbable tubular device intended to be implanted within the descending thoracic aorta to repair the vessel [includes repair of thoracic aortic aneurysm (TAA), traumatic transsections/dissections, fistulae, penetrating ulcers]; it is not intended for implantation within the aortic arch. It is typically made of a metal alloy [e.g., nickel-titanium alloy (Nitinol)] that forms an outer mesh structure with an inner synthetic polymer tube (endovascular graft) and is typically designed as a single continuous tube which may be used in singular and/or modular configurations. It is intended for percutaneous introduction; disposable delivery device (e.g., balloon catheter) may be included.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
PNF | Aortic stent |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P150028 | 000 |
P150028 | 002 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: KEEP AWAY FROM SUNLIGHT |
Storage Environment Temperature: between 4 and 45 Degrees Celsius |
Special Storage Condition, Specify: |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
35e13c39-8cef-4ddb-ad44-67de9d2f4ded
April 18, 2025
7
April 14, 2019
April 18, 2025
7
April 14, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(877)836-2228
GUDID.BBMUS_Service@bbraun.com
GUDID.BBMUS_Service@bbraun.com