DEVICE: NuDEL (04046955218691)

Device Identifier (DI) Information

NuDEL
614587
In Commercial Distribution
614587
B BRAUN INTERVENTIONAL SYSTEMS, INC
04046955218691
GS1

1
784259751 *Terms of Use
DEL028 NUDEL STENT DELSYS 4.5 24 5 14F
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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
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FDA Product Code

[?]
Product Code Product Code Name
PNF Aortic stent
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P150028 000
P150028 002
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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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:
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

35e13c39-8cef-4ddb-ad44-67de9d2f4ded
April 18, 2025
7
April 14, 2019
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(877)836-2228
GUDID.BBMUS_Service@bbraun.com
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