Catalog Number

DI-5417

Brand Name

Coulmed

Version/Model Number

DI-5417

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"

-

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

K101689,K101689

Product Code

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

480b6f91-c0c4-4370-a541-ff6295142a82

Public Version Date

February 06, 2020

Public Version Number

2

DI Record Publish Date

May 28, 2019

Package DI Number

00850003355351

Quantity per Package

20

Contains DI Package

00850003355344

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case