Catalog Number

-

Brand Name

SoftSeal

Version/Model Number

2150

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K090100,K090100

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

ab1a14af-2b88-4c59-97a8-0cfce2b21d2b

Public Version Date

November 06, 2020

Public Version Number

1

DI Record Publish Date

October 29, 2020

Package DI Number

10862499000209

Quantity per Package

10

Contains DI Package

00862499000202

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-