Catalog Number

PD-150

Brand Name

ISI

Version/Model Number

Foam Pad - Ultra Light / Self Supporting / Free Standing

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

FSE

Product Code Name

Table, Operating-Room, Manual

Public Device Record Key

5f4a5f7d-62f2-472b-9867-d811a53c474c

Public Version Date

July 31, 2020

Public Version Number

1

DI Record Publish Date

July 23, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-