Diamatrix - Diamatrix Economy Series Diamond Knife, Standard - Diamatrix

Duns Number:809555139

Device Description: Diamatrix Economy Series Diamond Knife, Standard Tri-Facet, .7mm, Standard Stab Handle

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More Product Details

Catalog Number

L03410.7E

Brand Name

Diamatrix

Version/Model Number

L03410.7E

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

fe1f9cf7-0230-4939-902b-91143f8493ef

Public Version Date

January 05, 2021

Public Version Number

1

DI Record Publish Date

December 28, 2020

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