Catalog Number

-

Brand Name

SSCOR Duet ®

Version/Model Number

2314BV-230

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"

-

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

ea3b43f7-72d9-4a5a-b450-c1e44a572fb9

Public Version Date

August 30, 2019

Public Version Number

1

DI Record Publish Date

August 22, 2019

Package DI Number

B2452314BV2301

Quantity per Package

1

Contains DI Package

B2452314BV2300

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton