Catalog Number

-

Brand Name

EAGLE VISION MONOSTENT-P

Version/Model Number

1084

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 31, 2017

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

-

Product Code

OKS

Product Code Name

Lacrimal Stents And Intubation Sets

Public Device Record Key

0550116d-6a51-4a11-ac58-cb04eba696d8

Public Version Date

December 11, 2019

Public Version Number

3

DI Record Publish Date

October 12, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-