Catalog Number

DI-1404A

Brand Name

Coulmed Products Group

Version/Model Number

DI-1404A

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

K101689,K101689

Product Code

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

12cd168b-321d-438d-97fa-31545b8d54a7

Public Version Date

May 18, 2021

Public Version Number

4

DI Record Publish Date

January 02, 2020

Package DI Number

00850015378003

Quantity per Package

12

Contains DI Package

00850003355993

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case