Catalog Number

OM1110/B

Brand Name

Huntington™

Version/Model Number

00884450412039

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GAA

Product Code Name

NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Public Device Record Key

a4e5218d-0e39-4781-96b9-5e3b36935147

Public Version Date

May 31, 2019

Public Version Number

1

DI Record Publish Date

May 23, 2019

Package DI Number

10884450412036

Quantity per Package

10

Contains DI Package

00884450412039

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-