Catalog Number

ET1310

Brand Name

EndoTNeedle

Version/Model Number

ET1310

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 06, 2022

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

-

Product Code

FBK

Product Code Name

Endoscopic Injection Needle, Gastroenterology-Urology

Public Device Record Key

c4052590-a7be-4e4e-ab8e-58a1a3dbd524

Public Version Date

September 16, 2022

Public Version Number

5

DI Record Publish Date

September 22, 2016

Package DI Number

10816207020171

Quantity per Package

10

Contains DI Package

00816207020174

Package Discontinue Date

June 06, 2022

Package Status

Not in Commercial Distribution

Package Type

Case