Catalog Number

-

Brand Name

EndoClot Applicator

Version/Model Number

EA230

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

K162197,K162197

Product Code

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Public Device Record Key

f3258f82-9a8a-4878-918f-df68728bde74

Public Version Date

July 01, 2021

Public Version Number

1

DI Record Publish Date

June 23, 2021

Package DI Number

46972011720111

Quantity per Package

5

Contains DI Package

16972011720110

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-