Catalog Number

IDT03

Brand Name

Soft Tipped Medial Mixing Tip(Blue)

Version/Model Number

IDT03

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 15, 2022

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

LDG

Product Code Name

Kit, Earmold, Impression

Public Device Record Key

f456c019-d78d-4f7b-8358-bc63e8416de8

Public Version Date

February 16, 2022

Public Version Number

2

DI Record Publish Date

June 22, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-