Catalog Number

-

Brand Name

20GA Bipolar Manipulator - Standard

Version/Model Number

PD103.12

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K980797,K980797

Product Code

MPA

Product Code Name

Endoilluminator

Public Device Record Key

dba886e0-580b-488a-9f31-3368f338a0da

Public Version Date

May 07, 2019

Public Version Number

4

DI Record Publish Date

May 06, 2016

Package DI Number

10632307001267

Quantity per Package

5

Contains DI Package

00632307001260

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box