Catalog Number

-

Brand Name

AVACEN

Version/Model Number

100-pack Mitts

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K133981

Product Code

IRT

Product Code Name

Pad, Heating, Powered

Public Device Record Key

68ac378e-391a-4d32-b444-17f3d99cec64

Public Version Date

July 07, 2020

Public Version Number

5

DI Record Publish Date

May 03, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-