Catalog Number

-

Brand Name

Alcedo

Version/Model Number

P5050

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

Yes

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

K152648,K152648

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

95ffa300-3331-4662-9035-6db9ab86d106

Public Version Date

September 17, 2020

Public Version Number

1

DI Record Publish Date

September 09, 2020

Package DI Number

16973265920080

Quantity per Package

2500

Contains DI Package

06973265920076

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-