Catalog Number

BGF1515U

Brand Name

BIOSORB®

Version/Model Number

BGF1515U

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

-

Product Code

NAC

Product Code Name

Dressing, Wound, Hydrophilic

Public Device Record Key

fbc18fcb-a396-41d4-b260-4981e95c5551

Public Version Date

July 22, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2019

Package DI Number

25051978008443

Quantity per Package

5

Contains DI Package

15051978008446

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-