Diamatrix Ltd. - Diamatrix E-Series Diamond Knife, MicroTrap, - Diamatrix

Duns Number:809555139

Device Description: Diamatrix E-Series Diamond Knife, MicroTrap, 1.5mm /1.8mm, Angled

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More Product Details

Catalog Number

N04886

Brand Name

Diamatrix Ltd.

Version/Model Number

N04886

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

HNN

Product Code Name

Knife, Ophthalmic

Device Record Status

Public Device Record Key

fa855640-eaf1-460a-95f1-76e8091b515c

Public Version Date

March 30, 2022

Public Version Number

1

DI Record Publish Date

March 22, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DIAMATRIX" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 475
U Unclassified 13