Catalog Number

-

Brand Name

TERUMO

Version/Model Number

NN2538R

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

K121607,K121607,K121607,K121607

Product Code

FMI

Product Code Name

Needle, hypodermic, single lumen

Public Device Record Key

7eb70a01-8fc3-4448-a9b3-575e5bfa7664

Public Version Date

October 23, 2019

Public Version Number

5

DI Record Publish Date

September 08, 2016

Package DI Number

74806017511998

Quantity per Package

10

Contains DI Package

54806017511994

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Carton