Catalog Number

DI-5415

Brand Name

Coulmed Dome Bag 68cm

Version/Model Number

DI-5415

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

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

78b3b719-cda6-45b2-bde4-3e303f62e843

Public Version Date

December 22, 2021

Public Version Number

3

DI Record Publish Date

July 11, 2019

Package DI Number

00850003355511

Quantity per Package

20

Contains DI Package

00850003355504

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case