Catalog Number

ITO-5L

Brand Name

EXCELLENT-COLORS

Version/Model Number

ITO-5L

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EBH

Product Code Name

Material, Impression Tray, Resin

Public Device Record Key

bf3299f8-6e3a-42ba-b1eb-2743b5524470

Public Version Date

December 22, 2021

Public Version Number

1

DI Record Publish Date

December 13, 2021

Package DI Number

D832ITO5L501

Quantity per Package

50

Contains DI Package

D832ITO5L1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BAG