Catalog Number

-

Brand Name

stay•safe® Handi-tool

Version/Model Number

030-10810-1

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

K173718,K173718

Product Code

FKX

Product Code Name

System, Peritoneal, Automatic Delivery

Public Device Record Key

bc3fd3e6-4be0-440c-842c-c95d13c4df10

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

May 09, 2019

Package DI Number

10840861102324

Quantity per Package

100

Contains DI Package

00840861102327

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case