Catalog Number

-

Brand Name

SAGE 1-Step

Version/Model Number

67010010D

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

Yes

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

-

FDA Premarket Submission

K133707

Product Code

MQL

Product Code Name

Media, Reproductive

Public Device Record Key

a5eda358-84a1-42fd-bca1-e8a0ca9d2ebc

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 22, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-