Sense Medical - Bipolar Pencil 18 Gauge Straight - SENSE MEDICAL LLC

Duns Number:159526008

Device Description: Bipolar Pencil 18 Gauge Straight

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


More Product Details

Catalog Number

-

Brand Name

Sense Medical

Version/Model Number

14500

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

K864402,K864402,K864402

Product Code Details

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Device Record Status

Public Device Record Key

80c0068c-0b71-47ce-8a54-7f0fd677e5d3

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 16, 2016

Additional Identifiers

Package DI Number

20841019110083

Quantity per Package

50

Contains DI Package

00841019110089

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"SENSE MEDICAL LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1