Catalog Number

-

Brand Name

Sorbalgon 4x8 5/Bx

Version/Model Number

49230001

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

NAC

Product Code Name

Dressing, Wound, Hydrophilic

Public Device Record Key

a8b56846-7294-49a3-bd0a-4bb33245c4b1

Public Version Date

July 22, 2021

Public Version Number

2

DI Record Publish Date

September 01, 2020

Package DI Number

04052199569833

Quantity per Package

5

Contains DI Package

04052199569826

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-