Catalog Number

-

Brand Name

N/A

Version/Model Number

ACRL-9000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 30, 2018

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

c1a1afbd-9687-45b2-bca2-b6cf3e6dcd8b

Public Version Date

February 19, 2021

Public Version Number

9

DI Record Publish Date

October 12, 2016

Package DI Number

50023601290002

Quantity per Package

4

Contains DI Package

30023601290008

Package Discontinue Date

May 30, 2018

Package Status

Not in Commercial Distribution

Package Type

CA