Catalog Number

90-010-14

Brand Name

Wiggins Medical

Version/Model Number

90-010-14

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

-

Product Code

JZF

Product Code Name

Tube, Ear Suction

Public Device Record Key

d3d56b31-51da-4036-9a9e-4621facce6a2

Public Version Date

September 20, 2022

Public Version Number

2

DI Record Publish Date

June 07, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-