Catalog Number

SRI-0202012

Brand Name

IDB 2

Version/Model Number

SRI-0202012

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

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

EBH

Product Code Name

Material, Impression Tray, Resin

Public Device Record Key

2a7f8d64-b895-4ad7-84c7-3e76633b8a4c

Public Version Date

March 08, 2022

Public Version Number

1

DI Record Publish Date

February 28, 2022

Package DI Number

10850039704052

Quantity per Package

1

Contains DI Package

00850039704055

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box