Catalog Number

169018 M

Brand Name

RELI

Version/Model Number

169018 M

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

25fc6b1c-f924-40ef-908f-d592c79a60fc

Public Version Date

March 09, 2022

Public Version Number

1

DI Record Publish Date

March 01, 2022

Package DI Number

20386120011275

Quantity per Package

10

Contains DI Package

10386120011278

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case