Catalog Number

-

Brand Name

XcelGel

Version/Model Number

PC1036 TALL

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 08, 2022

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

LWG

Product Code Name

Surgical Table Cushion

Public Device Record Key

99512512-e2c0-444c-a5aa-cca667dd2cc1

Public Version Date

September 09, 2022

Public Version Number

3

DI Record Publish Date

June 18, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-