MedVat - Ultrasonic Gel with Aloe Vera - PARKER LABORATORIES INC

Duns Number:002449593

Device Description: Ultrasonic Gel with Aloe Vera

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More Product Details

Catalog Number

-

Brand Name

MedVat

Version/Model Number

MED-USG-CLEAR-8.5OZ-A

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

-

Product Code Details

Product Code

MUI

Product Code Name

Media, Coupling, Ultrasound

Device Record Status

Public Device Record Key

bbb467a9-60a9-4fba-b228-baecbf1ed85e

Public Version Date

October 12, 2021

Public Version Number

1

DI Record Publish Date

October 04, 2021

Additional Identifiers

Package DI Number

10855683006835

Quantity per Package

12

Contains DI Package

00855683006838

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Box

"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