Catalog Number

1948DZ

Brand Name

PILLOW, GENTLETOUCH, 4 INCH PEDI

Version/Model Number

1948

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

CCX

Product Code Name

Support, Patient Position

Public Device Record Key

a6f2c886-7f22-431c-8f03-8f7eab551fd0

Public Version Date

December 22, 2020

Public Version Number

1

DI Record Publish Date

December 14, 2020

Package DI Number

10842430110075

Quantity per Package

12

Contains DI Package

00842430110078

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case