9.7MHZ ADULT FLAT PROBE - PARKS MEDICAL ELECTRONICS, INC.

Duns Number:009041773

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More Product Details

Catalog Number

-

Brand Name

9.7MHZ ADULT FLAT PROBE

Version/Model Number

832-3970-11

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

-

Prescription Use (Rx)

Yes

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

JOP

Product Code Name

TRANSDUCER, ULTRASONIC

Device Record Status

Public Device Record Key

e5773363-9d7b-4f46-a6b9-70463be1a315

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PARKS MEDICAL ELECTRONICS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 434