Catalog Number

-

Brand Name

SORBALUX ABD PAD ST 8X10 320/CS

Version/Model Number

48720000

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

d7feb33c-0b46-4db7-a60b-3fac4a5ac1b1

Public Version Date

August 24, 2021

Public Version Number

2

DI Record Publish Date

September 01, 2020

Package DI Number

40612553017046

Quantity per Package

16

Contains DI Package

10612553017045

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-