Catalog Number

-

Brand Name

BLDG Active

Version/Model Number

1403

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

-

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

K150799,K150799

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

1599a698-3b29-4ef5-a619-4ba04ba45947

Public Version Date

October 28, 2022

Public Version Number

1

DI Record Publish Date

October 20, 2022

Package DI Number

10818582012420

Quantity per Package

6

Contains DI Package

00818582012423

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box