Duckworth & Kent - Spatula - DUCKWORTH AND KENT LIMITED

Duns Number:217182583

Device Description: Spatula

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More Product Details

Catalog Number

6-105-1

Brand Name

Duckworth & Kent

Version/Model Number

6-105-1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 01, 2022

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

HND

Product Code Name

Spatula, Ophthalmic

Device Record Status

Public Device Record Key

3e42fe93-0f11-4a05-b3b0-1a64100a952f

Public Version Date

September 09, 2022

Public Version Number

2

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