Diamatrix - Diamatrix Diamond Knife, Standard Tri-Facet, - Diamatrix

Duns Number:809555139

Device Description: Diamatrix Diamond Knife, Standard Tri-Facet, Fixed Depth

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More Product Details

Catalog Number

-

Brand Name

Diamatrix

Version/Model Number

N07410

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

812dcbee-76e9-4d7f-acda-710772fcb619

Public Version Date

December 17, 2019

Public Version Number

1

DI Record Publish Date

December 09, 2019

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