Catalog Number

-

Brand Name

ECLIPSE

Version/Model Number

PRPB-368652

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

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

91b49d15-79eb-430e-b7a7-986c40bfffea

Public Version Date

March 21, 2022

Public Version Number

1

DI Record Publish Date

March 11, 2022

Package DI Number

16935550817024

Quantity per Package

50

Contains DI Package

06935550817027

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box