Catalog Number

-

Brand Name

SORBALUX ABD PAD ST 3x5 400/CS

Version/Model Number

15700004

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)

Yes

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

bf18b22e-637c-4344-a91b-5e3e0066e294

Public Version Date

December 30, 2021

Public Version Number

1

DI Record Publish Date

December 22, 2021

Package DI Number

04052199583594

Quantity per Package

25

Contains DI Package

04052199583587

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-