BOVIE - REPLACEABLE LOOP TIP - BOVIE MEDICAL CORPORATION

Duns Number:079940465

Device Description: REPLACEABLE LOOP TIP

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

H103

Brand Name

BOVIE

Version/Model Number

H103

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)

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

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Device Record Status

Public Device Record Key

7c9fd0e4-abc6-4347-bf35-b4466e56aae7

Public Version Date

February 07, 2019

Public Version Number

3

DI Record Publish Date

September 21, 2016

Additional Identifiers

Package DI Number

10607151071032

Quantity per Package

10

Contains DI Package

00607151071035

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX

"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