DEVICE: Cordis PRECISE PRO Rx Nitinol Stent System (20705032036525)

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Device Record History
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Device Identifier (DI) Information
Cordis PRECISE PRO Rx Nitinol Stent System
PC0940RXC
In Commercial Distribution
PC0940RXC
CORDIS CORPORATION
20705032036525
GS1

1
806136177 *Terms of Use
No description.
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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?
45851 Bare-metal carotid artery stent
A non-bioabsorbable tubular device dedicated to implantation in a carotid artery to maintain arterial patency and improve luminal diameter in patients with atherosclerotic disease. It is made of metal [e.g., nickel-titanium alloy (Nitinol)] typically in a tubular mesh structure, and is typically delivered to the site of implantation by a dedicated instrument where it self-expands upon release. It is available in a variety of lengths and diameters and may be used in conjunction with an embolic protection device. Disposable devices associated with implantation may be included.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
NIM STENT, CAROTID
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
P030047 025
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 dry
Special Storage Condition, Specify: Keep away from sunlight
Special Storage Condition, Specify: Do not use if package is damaged
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
04d3329f-6342-467e-b23f-5d425ddef6bc
October 14, 2024
9
September 17, 2014
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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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