Catalog Number

-

Brand Name

EndoClot

Version/Model Number

EPK2302-01

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K190677,K190677,K190677

Product Code

QAU

Product Code Name

Hemostatic Device For Endoscopic Gastrointestinal Use

Public Device Record Key

572be470-df59-4bec-8bdf-01b1b1c017c9

Public Version Date

March 23, 2022

Public Version Number

1

DI Record Publish Date

March 15, 2022

Package DI Number

26972011720018

Quantity per Package

1

Contains DI Package

16972011720011

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-