Misago®

Basic Information

• Brand Name: Misago®
• Primary DI: 04987350722126
• Version / Model: SXR06120L
• Catalog Number: SX*FXA06X2LN
• Company Name: TERUMO CORPORATION
• Labeler DUNS: 690543319
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-05-30
• Public Version: 6
• Public Version Date: 2023-02-03
• Public Version Status: Update
• Public Device Record Key: f80ba4f1-9ace-4a23-abf6-e8cf37031b8f

Device Description

MISAGO RX Self-expanding Peripheral Stent

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NIP	Stent, Superficial Femoral Artery	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	54987350722121	GS1	Carton	5	In Commercial Distribution
Primary	04987350722126	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Distal Tip and Sheath are coated with Hydrophilic Polymer
Device Size Text, specify			Catheter Usable Length: 135 centimeters
Length	120	Millimeter
Lumen/Inner Diameter	6	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Fragile, handle with care. Keep dry. Keep away from sunlight. Stacking limit by 9.