Catalog Number

-

Brand Name

XCELGEL

Version/Model Number

PC1029-0

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)

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

18a9f860-f8d7-4dc6-b7e6-c1f18cb6860f

Public Version Date

November 19, 2020

Public Version Number

2

DI Record Publish Date

June 15, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-