Disposable PowerGrip Bipolar Instrument Cord - ENCISION, INC.

Duns Number:612250175

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More Product Details

Catalog Number

BP4510

Brand Name

Disposable PowerGrip Bipolar Instrument Cord

Version/Model Number

BP4510

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 21, 2018

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"

Yes

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

929fa583-5871-4522-a499-23296fcb7621

Public Version Date

October 19, 2020

Public Version Number

6

DI Record Publish Date

August 31, 2016

Additional Identifiers

Package DI Number

30815288013373

Quantity per Package

50

Contains DI Package

10815288013379

Package Discontinue Date

May 21, 2018

Package Status

Not in Commercial Distribution

Package Type

-

"ENCISION, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 208