Catalog Number

-

Brand Name

iSage Rx

Version/Model Number

Version 2.X

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

K161865

Product Code

NDC

Product Code Name

Calculator, Drug Dose

Public Device Record Key

8dbe6f6d-4d74-43a6-a6df-7ad08723185a

Public Version Date

October 24, 2022

Public Version Number

3

DI Record Publish Date

December 07, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-