Catalog Number

-

Brand Name

Saber®Bulb Evacuators

Version/Model Number

310101

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GCY

Product Code Name

APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Public Device Record Key

1079d630-0eca-43c3-8096-11c2a269551d

Public Version Date

March 08, 2022

Public Version Number

2

DI Record Publish Date

February 25, 2021

Package DI Number

00840113224746

Quantity per Package

10

Contains DI Package

00840113224739

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-