Catalog Number

-

Brand Name

SORBALUX PURP SPONGE ST 4X4 4PLY 1200/CS

Version/Model Number

48880000

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

NAB

Product Code Name

Gauze / Sponge,Nonresorbable For External Use

Public Device Record Key

c4a271f7-a554-40e1-adb4-99ab4851b445

Public Version Date

August 24, 2021

Public Version Number

2

DI Record Publish Date

September 01, 2020

Package DI Number

20612553017585

Quantity per Package

600

Contains DI Package

10612553017588

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-