Catalog Number

GSN-05-19-180

Brand Name

Injectra, Sclero Tip

Version/Model Number

GSN-05-19-180

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"

-

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

391aaeed-5537-4ca9-bc3a-667226868408

Public Version Date

May 23, 2019

Public Version Number

1

DI Record Publish Date

May 15, 2019

Package DI Number

04052838009669

Quantity per Package

10

Contains DI Package

04052838009652

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box