Catalog Number

NS-BCTH

Brand Name

RELI

Version/Model Number

NS-BCTH

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

K173279,K173279,K173279

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

ddb648db-112a-49f3-896b-76242a206ade

Public Version Date

April 23, 2019

Public Version Number

2

DI Record Publish Date

January 07, 2019

Package DI Number

20386120009203

Quantity per Package

20

Contains DI Package

10386120009206

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case