Catalog Number

-

Brand Name

Large Dilator Tube

Version/Model Number

7332-76D

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

-

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

K120590

Product Code

GXZ

Product Code Name

Electrode, Needle

Public Device Record Key

e2586c09-3c28-4a3c-a643-027e182c10cf

Public Version Date

February 08, 2022

Public Version Number

1

DI Record Publish Date

January 31, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-