Catalog Number

-

Brand Name

Walcott Rx Products

Version/Model Number

Rx002-19

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

HMX

Product Code Name

Cannula, Ophthalmic

Public Device Record Key

b957270f-be75-42ea-b714-40356c876bf5

Public Version Date

October 24, 2022

Public Version Number

1

DI Record Publish Date

October 14, 2022

Package DI Number

10840285320144

Quantity per Package

5

Contains DI Package

00840285320147

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pack