Catalog Number

ET1301

Brand Name

EndoTNeedle

Version/Model Number

ET1301

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

-

Product Code

FBK

Product Code Name

Endoscopic Injection Needle, Gastroenterology-Urology

Public Device Record Key

3ceb9bc1-e0f2-4383-97d0-d8b2b42b56e3

Public Version Date

December 14, 2020

Public Version Number

3

DI Record Publish Date

May 14, 2018

Package DI Number

10816207021055

Quantity per Package

10

Contains DI Package

00816207021058

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box