Diamatrix Ltd. - Osher-Neumann Corneal Marker 8 Blade, Diamond - Diamatrix

Duns Number:809555139

Device Description: Osher-Neumann Corneal Marker 8 Blade, Diamond knurled handle, 118mm total length, Stainles Osher-Neumann Corneal Marker 8 Blade, Diamond knurled handle, 118mm total length, Stainless

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More Product Details

Catalog Number

M20-8

Brand Name

Diamatrix Ltd.

Version/Model Number

M20-8

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

HNQ

Product Code Name

Hook, Ophthalmic

Device Record Status

Public Device Record Key

d792d9c2-a743-4e9f-9e1c-bdcac9ec0093

Public Version Date

September 20, 2022

Public Version Number

1

DI Record Publish Date

September 12, 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