Catalog Number

-

Brand Name

SSCOR DUET

Version/Model Number

2314B

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

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

BTA

Product Code Name

Pump, Portable, Aspiration (Manual Or Powered)

Public Device Record Key

51f42427-af4b-4be4-97ba-6c16b54e9655

Public Version Date

August 23, 2019

Public Version Number

4

DI Record Publish Date

September 16, 2016

Package DI Number

B2452314B1

Quantity per Package

1

Contains DI Package

B2452314B0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton