Catalog Number

SELSIL-TRANS-B

Brand Name

Select Transbite

Version/Model Number

SELSIL-TRANS-B

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

ELW

Product Code Name

Material, Impression

Public Device Record Key

1e193d81-feca-453e-8849-d6cb2a323e50

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 16, 2017

Package DI Number

17540208000377

Quantity per Package

2

Contains DI Package

07540208000370

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton