AccessGUDID - DEVICE: Misago® (04987350722362)

GUDID

Device Identifier (DI) Information

Brand Name: Misago®
Version or Model: SXR06100L
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SX*FXA06X0LN
Company Name: TERUMO CORPORATION

Primary DI Number: 04987350722362
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 9999
Device Count: 1
Labeler D-U-N-S® Number*: 690543319 *Terms of Use

Device Description: MISAGO RX Self-expanding Peripheral Stent

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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, pulmonary, 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, and not intended for connection with an aortic stent. It is made entirely of metal [e.g., Nitinol alloy mesh structure] and 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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Catheter Usable Length 135 centimeters
Length: 100 Millimeter
Lumen/Inner Diameter: 6 Millimeter

Device Record Status

Public Device Record Key: f3d40a02-83a0-40ff-9537-9710e118197e
Public Version Date: December 11, 2024
Public Version Number: 6
DI Record Publish Date: May 30, 2015