Catalog Number

DYNDH1438

Brand Name

Medline Industries, Inc.

Version/Model Number

DYNDH1438

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

K982541

Product Code

FMI

Product Code Name

Needle, hypodermic, single lumen

Public Device Record Key

482f96ca-1dee-4869-bccd-d76b4d5b3e8b

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

January 09, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-