Catalog Number

-

Brand Name

Alcedo

Version/Model Number

AE177

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

GZJ

Product Code Name

Stimulator, Nerve, Transcutaneous, For Pain Relief

Public Device Record Key

e21c1434-9f5e-4ffe-9393-10f98b6a3d0e

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

July 30, 2020

Package DI Number

20856471007239

Quantity per Package

50

Contains DI Package

00856471007235

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master carton