Catalog Number

DI-1416

Brand Name

Coulmed

Version/Model Number

DI-1416

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

70806cc3-6465-42ac-a253-371001971459

Public Version Date

May 04, 2021

Public Version Number

1

DI Record Publish Date

April 26, 2021

Package DI Number

00850024023949

Quantity per Package

10

Contains DI Package

00850024023932

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case