Catalog Number

-

Brand Name

FLEXICOL 4X4 10/BX

Version/Model Number

48610000

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

NAD

Product Code Name

Dressing, Wound, Occlusive

Public Device Record Key

4b4226ea-e0eb-450f-8a38-b29892763c84

Public Version Date

July 22, 2021

Public Version Number

2

DI Record Publish Date

September 01, 2020

Package DI Number

40612553013710

Quantity per Package

20

Contains DI Package

20612553013716

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-