Catalog Number

-

Brand Name

1byone

Version/Model Number

PL-029K16B-P3

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

-

Product Code

IRT

Product Code Name

Pad, Heating, Powered

Public Device Record Key

4a61522a-bee0-4c66-b460-cfe19de295ac

Public Version Date

June 05, 2020

Public Version Number

2

DI Record Publish Date

December 14, 2019

Package DI Number

00858069007115

Quantity per Package

1

Contains DI Package

00858069007085

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

gift box