Catalog Number

661520

Brand Name

Hopkins Medical Products®

Version/Model Number

661520

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K980490

Product Code

MMK

Product Code Name

Container, sharps

Public Device Record Key

775966af-0923-4258-93fa-83a95e33f3ff

Public Version Date

November 01, 2018

Public Version Number

1

DI Record Publish Date

October 01, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-