Catalog Number

2C0415

Brand Name

NA

Version/Model Number

2C0415

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

-

Product Code

NEP

Product Code Name

SYSTEM/DEVICE, PHARMACY COMPOUNDING

Public Device Record Key

d473fe82-2110-4615-997e-8bcb7f197220

Public Version Date

October 11, 2022

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

50085412000348

Quantity per Package

48

Contains DI Package

00085412000343

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE