Catalog Number

3910-004-042

Brand Name

Xcel

Version/Model Number

3910-004-042

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 03, 2015

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

HWJ

Product Code Name

AWL

Public Device Record Key

6838b4a9-1ed6-4991-9c12-a6ea3fc6f6c0

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

September 04, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-