Catalog Number

ET2035

Brand Name

EndoTBasket

Version/Model Number

ET2035

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K800970,K800970

Product Code

OCZ

Product Code Name

Endoscopic Grasping/Cutting Instrument, Non-Powered

Public Device Record Key

2b8ecefa-0725-4bc4-9f0f-7095c7d83c01

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

September 22, 2016

Package DI Number

10816207020041

Quantity per Package

10

Contains DI Package

00816207020044

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box