Misago® - MISAGO RX Self-expanding Peripheral Stent - TERUMO CORPORATION

Duns Number:690543319

Device Description: MISAGO RX Self-expanding Peripheral Stent

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More Product Details

Catalog Number

SX*FXA06X5LN

Brand Name

Misago®

Version/Model Number

SXR06150L

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

NIP

Product Code Name

Stent, Superficial Femoral Artery

Device Record Status

Public Device Record Key

5b3c3460-9317-4874-a696-e2fd21ab7fac

Public Version Date

April 08, 2022

Public Version Number

5

DI Record Publish Date

May 30, 2015

Additional Identifiers

Package DI Number

54987350722145

Quantity per Package

5

Contains DI Package

04987350722140

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"TERUMO CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 11
2 A medical device with a moderate to high risk that requires special controls. 364
3 A medical device with high risk that requires premarket approval 29