DEVICE: S.M.A.R.T. RADIANZ (20705032082577)

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Device Record History
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Device Identifier (DI) Information
S.M.A.R.T. RADIANZ
SR09060L
In Commercial Distribution
SR09060L
CORDIS CORPORATION
20705032082577
GS1

1
806136177 *Terms of Use
S.M.A.R.T. RADIANZ Vascular Stent System 9x60mm 150CM
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Device Characteristics
MR Conditional
No
Yes
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?
47932 Peripheral artery stent, bare-metal
A non-bioabsorbable tubular device intended to be implanted in a peripheral artery (excludes aorta, coronary, pulmonary, and intracranial arteries) to indefinitely maintain patency and improve luminal diameter in patients with atherosclerotic disease, or following the recanalization of a total occlusion. It may additionally be intended to be implanted in an obstructed biliary duct; it is not dedicated to carotid artery implantation, and not intended for connection with an aortic stent. It is made entirely of metal [e.g., Nitinol alloy mesh structure] and typically implanted by a dedicated instrument where it self-expands upon release or is balloon expanded.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
NIP STENT, SUPERFICIAL FEMORAL ARTERY
NIO STENT, ILIAC
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
P020036 000
No CLOSE

Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 15 and 30 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
5691f2f7-9734-4e4c-a7db-95851bea4d09
December 11, 2024
7
April 15, 2022
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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

[?]
No Customer Contact currently defined
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