Catalog Number

-

Brand Name

ProTekt

Version/Model Number

PG 44610MU

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

-

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

HNN

Product Code Name

Knife, Ophthalmic

Public Device Record Key

66049cac-6e9d-446e-8038-b03adbba943c

Public Version Date

November 01, 2019

Public Version Number

1

DI Record Publish Date

October 24, 2019

Package DI Number

00813059011626

Quantity per Package

6

Contains DI Package

00813059012036

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box