Catalog Number

-

Brand Name

N/A

Version/Model Number

xACRL-5500

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 01, 2019

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

-

Product Code

NUH

Product Code Name

Stimulator, Nerve, Transcutaneous, Over-The-Counter

Public Device Record Key

cbe39519-508d-45b4-bbf9-c8f7ef263aa6

Public Version Date

February 19, 2021

Public Version Number

9

DI Record Publish Date

October 12, 2016

Package DI Number

30023601255007

Quantity per Package

2

Contains DI Package

90002360125501

Package Discontinue Date

September 01, 2019

Package Status

Not in Commercial Distribution

Package Type

CA