Catalog Number

0070850

Brand Name

Closed Wound Suction

Version/Model Number

0070850

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)

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

38ba9d72-d63a-4c71-a301-8d08ba18a67b

Public Version Date

September 30, 2020

Public Version Number

1

DI Record Publish Date

September 22, 2020

Package DI Number

10801741049610

Quantity per Package

10

Contains DI Package

00801741049613

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX