Catalog Number

N05490E

Brand Name

Diamatrix Ltd.

Version/Model Number

N05490E

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

bc660e92-b6ac-4021-aea2-9c6d284c7ba4

Public Version Date

December 07, 2021

Public Version Number

1

DI Record Publish Date

November 29, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-