Catalog Number

50PRP2500-N30gx13mm

Brand Name

Eclipse Hypodermic Needle - 30G

Version/Model Number

50PRP2500-N30gx13mm

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

K172938

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

62c3de8a-7876-41d0-95e2-21a27373e034

Public Version Date

January 19, 2022

Public Version Number

1

DI Record Publish Date

January 11, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-