Catalog Number

M4

Brand Name

Ahmed™ Glaucoma Valve

Version/Model Number

M4

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 22, 2016

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

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

KYF

Product Code Name

IMPLANT, EYE VALVE

Public Device Record Key

b6000fa2-bc14-40e3-914b-d926e535fbc7

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

March 24, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-