Catalog Number

Silicone Rendell Baker Mask, Size 0

Brand Name

N/A

Version/Model Number

5150

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"

Yes

For Single-Use

-

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

BSJ

Product Code Name

Mask, Gas, Anesthetic

Public Device Record Key

feee2bc3-580d-4909-8254-4a1f85fb2124

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 15, 2015

Package DI Number

44710810081758

Quantity per Package

12

Contains DI Package

24710810081754

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton