Catalog Number

PMWPAD-M

Brand Name

Avail Wireless Pad

Version/Model Number

PMWPAD-M

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)

Yes

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

K172079,K172079,K172079

Product Code

NUH

Product Code Name

Stimulator, Nerve, Transcutaneous, Over-The-Counter

Public Device Record Key

4c0dafc0-7b92-4aaf-80d0-cd01e53c311a

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

December 15, 2017

Package DI Number

20073796346144

Quantity per Package

4

Contains DI Package

10073796346147

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case