Catalog Number

1SEAL

Brand Name

ENDOPATH

Version/Model Number

1SEAL

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 02, 2020

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

-

Product Code

HET

Product Code Name

LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

Public Device Record Key

b17ba41c-fcc8-45b3-9f0e-dde442312218

Public Version Date

November 03, 2020

Public Version Number

3

DI Record Publish Date

July 15, 2016

Package DI Number

40705036011942

Quantity per Package

252

Contains DI Package

20705036011948

Package Discontinue Date

November 02, 2020

Package Status

Not in Commercial Distribution

Package Type

CASE