Catalog Number

ALFA01

Brand Name

Isiris™ aStent Removal Device

Version/Model Number

ALFA01

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

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

FAJ

Product Code Name

Cystoscope and accessories, flexible/rigid

Public Device Record Key

ff684a8a-f76f-48e5-9807-b7cf02fb6055

Public Version Date

November 04, 2019

Public Version Number

2

DI Record Publish Date

July 30, 2018

Package DI Number

05707480136056

Quantity per Package

5

Contains DI Package

05707480136063

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-