Catalog Number

SSH-1

Brand Name

IOPS™

Version/Model Number

SSH-1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K190106,K190106

Product Code

DQK

Product Code Name

Computer, Diagnostic, Programmable

Public Device Record Key

3db94fa6-6db9-45f5-9d6e-1ffa6122cf72

Public Version Date

October 29, 2020

Public Version Number

1

DI Record Publish Date

October 21, 2020

Package DI Number

10843152102010

Quantity per Package

5

Contains DI Package

00843152102013

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box