Catalog Number

-

Brand Name

1byone

Version/Model Number

PL-029K16B

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

-

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

28faff53-d53b-42f7-b964-03572a09ad80

Public Version Date

June 05, 2020

Public Version Number

2

DI Record Publish Date

December 12, 2019

Package DI Number

10858069007129

Quantity per Package

24

Contains DI Package

00858069007122

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton