Catalog Number

69493AVB

Brand Name

AVRA BACK 3IN SKYTRON 3500, STERIS 4085

Version/Model Number

69493AVB

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

JFC

Product Code Name

System, Pressure Measurement, Intermittent

Public Device Record Key

746c4db2-2ea1-4689-bf59-8724acf06747

Public Version Date

September 23, 2021

Public Version Number

2

DI Record Publish Date

July 07, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-