Catalog Number

89-10585

Brand Name

DeRoyal

Version/Model Number

89-10585

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

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

OGK

Product Code Name

Orotracheal intubation guide kit

Public Device Record Key

e503caec-2c4d-44c2-b283-c8c2ad14cf9c

Public Version Date

May 17, 2021

Public Version Number

1

DI Record Publish Date

May 07, 2021

Package DI Number

50749756364244

Quantity per Package

14

Contains DI Package

00749756364249

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case