Catalog Number

SIS-15-01

Brand Name

EndoClot SIS

Version/Model Number

SIS-15-01

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

K191254,K191254,K191254

Product Code

PLL

Product Code Name

Submucosal Injection Agent

Public Device Record Key

5cf4b479-a559-4193-81c7-f9871ce0b06d

Public Version Date

November 24, 2021

Public Version Number

1

DI Record Publish Date

November 16, 2021

Package DI Number

26972011720254

Quantity per Package

5

Contains DI Package

16972011720257

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelf Box