Catalog Number

-

Brand Name

WELL-LIFE

Version/Model Number

WR-2605

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 15, 2019

Issuing Agency

In GS1

MRI safety Status

MR Safe

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K161453,K161453

Product Code

NGY

Product Code Name

Cannula, Trocar, Ophthalmic

Public Device Record Key

f3804912-2acd-4ac8-84f7-6e9d97755cf8

Public Version Date

May 23, 2019

Public Version Number

5

DI Record Publish Date

March 15, 2017

Package DI Number

94719872266054

Quantity per Package

20

Contains DI Package

04719872266051

Package Discontinue Date

February 28, 2017

Package Status

Not in Commercial Distribution

Package Type

-