Catalog Number

-

Brand Name

All-Med, Inc.

Version/Model Number

55-2035

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

456a8845-6adb-4d98-9294-155d5085b0c5

Public Version Date

October 23, 2019

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

10816339027857

Quantity per Package

12

Contains DI Package

10816339021442

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-