Bovie - ACUDOP II 330R, NON-DISPLAY RECHARGEABLE UNIT - BOVIE MEDICAL CORPORATION

Duns Number:079940465

Device Description: ACUDOP II 330R, NON-DISPLAY RECHARGEABLE UNIT WITH 8MHZ VASCULAR PROBE

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More Product Details

Catalog Number

AD-330R-A8

Brand Name

Bovie

Version/Model Number

AD-330R-A8

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

K090465

Product Code Details

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Device Record Status

Public Device Record Key

fe538bf9-07ae-427a-b1a2-93b7d421adff

Public Version Date

June 28, 2019

Public Version Number

4

DI Record Publish Date

March 30, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BOVIE MEDICAL CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 13
2 A medical device with a moderate to high risk that requires special controls. 433