Catalog Number

6561

Brand Name

Sage

Version/Model Number

6561

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

-

Product Code

JOL

Product Code Name

CATHETER AND TIP, SUCTION

Public Device Record Key

997a8e34-512c-43cf-9c2e-80a23a9121d3

Public Version Date

July 07, 2020

Public Version Number

4

DI Record Publish Date

April 24, 2018

Package DI Number

50618029821527

Quantity per Package

100

Contains DI Package

00618029821522

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case