Catalog Number

0043650

Brand Name

Closed Wound Suction

Version/Model Number

0043650

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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)

Yes

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

c43a3bed-4795-4dc4-b54d-2ce8c19d15cc

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

September 22, 2020

Package DI Number

10801741049382

Quantity per Package

5

Contains DI Package

00801741049385

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX