Catalog Number

MR17019001

Brand Name

N/A

Version/Model Number

MR17019001

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K951254,K951254

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

0784d34e-1788-47d4-a046-123d51a57928

Public Version Date

October 23, 2019

Public Version Number

3

DI Record Publish Date

July 02, 2019

Package DI Number

50884908093686

Quantity per Package

3

Contains DI Package

00884908093681

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box