Catalog Number

66076088

Brand Name

Ivory

Version/Model Number

66076088

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FMA

Product Code Name

DEPRESSOR, TONGUE, NON-SURGICAL

Public Device Record Key

87cbb32e-0295-4ac5-ad81-d7dfb5334d5c

Public Version Date

August 06, 2018

Public Version Number

1

DI Record Publish Date

July 04, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-