Catalog Number

-

Brand Name

BGEcare Sterile Non-woven Island Dressing

Version/Model Number

ID040401500403S

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

NAC

Product Code Name

Dressing, Wound, Hydrophilic

Public Device Record Key

04b30489-357d-4783-9335-06e46dce05e5

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

March 04, 2021

Package DI Number

06959385794346

Quantity per Package

50

Contains DI Package

06959385794339

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box