Catalog Number

-

Brand Name

P-K Titanium Motility Peg System

Version/Model Number

I00089

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"

-

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

K974203

Product Code

MQU

Product Code Name

Ocular Peg

Public Device Record Key

37bac3b3-2030-431c-8a2a-7e778e3895b4

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 01, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-