Catalog Number

-

Brand Name

Needle

Version/Model Number

3910-900-119

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

HWQ

Product Code Name

Passer

Public Device Record Key

5c93495d-d0d4-4ca2-8389-ee98bca1fbbd

Public Version Date

August 01, 2022

Public Version Number

1

DI Record Publish Date

July 22, 2022

Package DI Number

10840277401103

Quantity per Package

12

Contains DI Package

00840277401106

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-