DEVICE: Misago® (04987350722225)
Device Identifier (DI) Information
Misago®
SXR07100L
In Commercial Distribution
SX*FXA07X0LN
TERUMO CORPORATION
SXR07100L
In Commercial Distribution
SX*FXA07X0LN
TERUMO CORPORATION
MISAGO RX Self-expanding Peripheral Stent
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? |
---|---|---|---|---|
47932 | Peripheral artery stent, bare-metal |
A non-bioabsorbable tubular device intended to be implanted in a peripheral artery (excludes aorta, coronary, 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. The stent is made entirely of metal [e.g., nickel-titanium alloy (Nitinol) mesh structure] and is typically implanted by a dedicated instrument where it self-expands upon release or is balloon expanded.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NIP | Stent, Superficial Femoral Artery |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Fragile, handle with care. Keep dry. Keep away from sunlight. Stacking limit by 9. |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Distal Tip and Sheath are coated with Hydrophilic Polymer |
Device Size Text, specify: Catheter Usable Length: 135 centimeters |
Length: 100 Millimeter |
Lumen/Inner Diameter: 7 Millimeter |
Device Record Status
1da13229-8b57-4205-97f2-ddfb646065fe
February 03, 2023
6
May 30, 2015
February 03, 2023
6
May 30, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
54987350722220 | 5 | 04987350722225 | In Commercial Distribution | Carton |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)283-7866
tmccustomer.admin@terumomedical.com
tmccustomer.admin@terumomedical.com