Catalog Number

5-010-17-B

Brand Name

Skytron

Version/Model Number

5-010-17-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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FQO

Product Code Name

TABLE, OPERATING-ROOM, AC-POWERED

Public Device Record Key

4bf26d1b-eb9c-4608-a83c-4045a0cc346e

Public Version Date

February 07, 2022

Public Version Number

1

DI Record Publish Date

January 29, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-