Catalog Number

E2183

Brand Name

Interventional Systems

Version/Model Number

E2183

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,K101689

Product Code

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

6898ff75-2564-46dc-a2d3-c118f4754259

Public Version Date

July 28, 2020

Public Version Number

1

DI Record Publish Date

July 20, 2020

Package DI Number

00850015378867

Quantity per Package

50

Contains DI Package

00850015378850

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

inner case