Catalog Number

-

Brand Name

LiNA OperåScope™ Needle 4mm

Version/Model Number

OP-NEE4-6

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

2b175dae-901e-4046-96d6-1118950a10e5

Public Version Date

October 11, 2022

Public Version Number

1

DI Record Publish Date

October 03, 2022

Package DI Number

05708265012305

Quantity per Package

6

Contains DI Package

05708265012299

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-