Duckworth & Kent - Blade Marker - DUCKWORTH AND KENT LIMITED

Duns Number:217182583

Device Description: Blade Marker

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More Product Details

Catalog Number

9-842-1

Brand Name

Duckworth & Kent

Version/Model Number

9-842-1

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)

-

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

3bee3843-cc29-43fe-abc6-5f03038f3919

Public Version Date

September 08, 2022

Public Version Number

1

DI Record Publish Date

August 31, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DUCKWORTH AND KENT LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 505