Catalog Number

-

Brand Name

PEDIATRIC EXTENSION

Version/Model Number

4-030-42

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LWG

Product Code Name

Surgical Table Cushion

Public Device Record Key

4a1be686-e17d-47fe-95a6-087fa3d1f2ba

Public Version Date

December 09, 2019

Public Version Number

1

DI Record Publish Date

December 01, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-