Catalog Number

-

Brand Name

Plastcare

Version/Model Number

RIT-5025

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Safe

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KYX

Product Code Name

Dispenser, Liquid Medication

Public Device Record Key

cbfc69a3-43b6-4671-8702-d67bf4de407e

Public Version Date

March 19, 2020

Public Version Number

1

DI Record Publish Date

March 11, 2020

Package DI Number

D915RIT50252

Quantity per Package

20

Contains DI Package

D915RIT50251

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-