Catalog Number

15502

Brand Name

Alcavis 50

Version/Model Number

200 mL Spray

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

-

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

FKO

Product Code Name

Catheter, Peritoneal Dialysis, Single Use

Public Device Record Key

309c971e-4fcc-4bec-925f-14323bf651c0

Public Version Date

March 19, 2021

Public Version Number

5

DI Record Publish Date

August 29, 2016

Package DI Number

20898021000062

Quantity per Package

4

Contains DI Package

00898021000068

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case