DEVICE: CP Stent™ (04046964899010)

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Device Identifier (DI) Information

CP Stent™
614320
614320
B BRAUN INTERVENTIONAL SYSTEMS, INC
04046964899010
GS1
1
MCP009 Mounted CP Stent 2.8 16 3 9F
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Device Characteristics

MR Conditional
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Bare-metal aortic stent A sterile non-bioabsorbable tubular device intended to be implanted in the aorta to maintain aortic patency and improve luminal diameter in patients with symptomatic atherosclerotic disease or recurrent coarctation (narrowing) of the aorta. It is made of metal (e.g., platinum/iridium wire with gold braze) and may be inserted with a balloon catheter which when inflated causes the device to expand, or the device may self-expand after being delivered to the site of implantation. The device is typically a mesh structure in tubular form; it is available in a variety of lengths and diameters. Disposable devices associated with implantation may be included.
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FDA Product Code

[?]
Product Code Product Code Name
PNF Aortic stent
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Sterilization

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

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Storage and Handling
Storage Environment Temperature: between 5 and 45 Degrees Celsius
Special Storage Condition, Specify: KEEP AWAY FROM SUNLIGHT
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Length : 28.000 MM
Device Size Text, specify: Diameter (mm) : 16.000 MM
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Device Status

In Commercial Distribution
May 19, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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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