Alpha-Stim - Conducting solution - PARKER LABORATORIES INC

Duns Number:002449593

Device Description: Conducting solution

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More Product Details

Catalog Number

SL50

Brand Name

Alpha-Stim

Version/Model Number

18-50-155614

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K780973,K780973

Product Code Details

Product Code

GYB

Product Code Name

Media, Electroconductive

Device Record Status

Public Device Record Key

e441c1a9-bcd5-4dd4-91f5-d39578adb521

Public Version Date

March 09, 2022

Public Version Number

1

DI Record Publish Date

March 01, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PARKER LABORATORIES INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 14