DEVICE: Misago® (04987350722126)

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Device Identifier (DI) Information

Misago®
SXR06120L
SX*FXA06X2LN
TERUMO CORPORATION
04987350722126
GS1
1
MISAGO RX Self-expanding Peripheral Stent
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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
Multiple peripheral artery stent, bare-metal A sterile non-bioabsorbable tubular device intended to be alternatively implanted in more than one peripheral artery (e.g., iliac, carotid, renal) to indefinitely maintain patency and improve luminal diameter in patients with atherosclerotic disease or following the recanalization of a total occlusion. It is typically implanted by a dedicated instrument where it self-expands upon release or is balloon expanded. It is made of metal [e.g., nickel-titanium alloy (Nitinol)] and may be a continuous tube of a certain length, a mesh structure, or other design for supporting constant blood flow through the artery. Some types may be used in the biliary duct as a secondary intended use.
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FDA Product Code

[?]
Product Code Product Code Name
NIP Stent, Superficial Femoral Artery
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Sterilization

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

[?]
Storage and Handling
Special Storage Condition, Specify: Stacking limit by 10
Special Storage Condition, Specify: Keep away from sunlight
Special Storage Condition, Specify: Keep dry
Special Storage Condition, Specify: Fragile
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Catheter Usable Length: 135 centimeters
Length: 120 Millimeter
Lumen/Inner Diameter: 6 Millimeter
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Device Status

In Commercial Distribution
May 30, 2015
December 31, 9999
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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
54987350722121 5 04987350722126 9999-12-31 In Commercial Distribution Carton
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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

[?]
18002837866
tmccustomer.admin@terumomedical.com
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