Catalog Number

RIGBR-LB-SH

Brand Name

Select Rigid BR

Version/Model Number

RIGBR-LB-SH

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

5c444ceb-99fd-48bf-b213-75a777c16316

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 21, 2017

Package DI Number

17540208000018

Quantity per Package

2

Contains DI Package

07540208000011

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton