Diamatrix - Lu-Mendez Degree Gauge and Fixation Ring, Marked - Diamatrix

Duns Number:809555139

Device Description: Lu-Mendez Degree Gauge and Fixation Ring, Marked in 10 Degree Increments, Conical Micro-Te Lu-Mendez Degree Gauge and Fixation Ring, Marked in 10 Degree Increments, Conical Micro-Teeth on Bottom of Ring, Stainless Steel.

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More Product Details

Catalog Number

M 24125-1

Brand Name

Diamatrix

Version/Model Number

M 24125-1

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

HMR

Product Code Name

Marker, Ocular

Device Record Status

Public Device Record Key

7b92e6f1-24e0-4e66-be82-2830701534c8

Public Version Date

July 10, 2020

Public Version Number

1

DI Record Publish Date

July 02, 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