Catalog Number

CT2109

Brand Name

Crystal Tip

Version/Model Number

CT2109

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

ECB

Product Code Name

UNIT, SYRINGE, AIR AND/OR WATER

Public Device Record Key

3653f4ff-f9b2-45d3-af52-7f52f4e43aaa

Public Version Date

October 31, 2022

Public Version Number

1

DI Record Publish Date

October 23, 2022

Package DI Number

10843471132484

Quantity per Package

1500

Contains DI Package

00843471132487

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Package