Catalog Number

20350-220

Brand Name

ERBE

Version/Model Number

20350-220

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 20, 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"

-

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

41fe3818-f412-4fd6-bcc3-758b71aed6d6

Public Version Date

October 25, 2022

Public Version Number

4

DI Record Publish Date

December 14, 2016

Package DI Number

04050147013780

Quantity per Package

16

Contains DI Package

04050147013773

Package Discontinue Date

October 20, 2022

Package Status

Not in Commercial Distribution

Package Type

Level: 2