Catalog Number

-

Brand Name

Chito-SAM™ 100

Version/Model Number

CT100-B-EN

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K133121,K133121

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

19efef60-808c-4567-b9e4-e192420882ff

Public Version Date

September 09, 2022

Public Version Number

1

DI Record Publish Date

September 01, 2022

Package DI Number

10822045000336

Quantity per Package

15

Contains DI Package

00822045000339

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case