Catalog Number

-

Brand Name

Clear-Jet Injection Catheter

Version/Model Number

FM-EI0002(I2)(2300)(0.05T)

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

K181690,K181690

Product Code

FBK

Product Code Name

Endoscopic Injection Needle, Gastroenterology-Urology

Public Device Record Key

eb1d9650-acc7-4903-95c8-20f24e08cfe3

Public Version Date

April 22, 2019

Public Version Number

1

DI Record Publish Date

April 12, 2019

Package DI Number

18809327350671

Quantity per Package

10

Contains DI Package

08809327350674

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box