Catalog Number

331

Brand Name

Dolphin Grasper Inner Shaft

Version/Model Number

331

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 29, 2021

Issuing Agency

In HIBCC

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

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

7cab9179-3a8f-43f4-89bd-9c6adbbe52e1

Public Version Date

March 29, 2021

Public Version Number

2

DI Record Publish Date

March 29, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-