DUCKLING - DUCKLING PUNCH BASKET ELEVATOR - Smith & Nephew, Inc.

Duns Number:109903521

Device Description: DUCKLING PUNCH BASKET ELEVATOR LOOP HANDLE

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More Product Details

Catalog Number

014765

Brand Name

DUCKLING

Version/Model Number

014765

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

NBH

Product Code Name

ACCESSORIES,ARTHROSCOPIC

Device Record Status

Public Device Record Key

380fa257-440b-42e9-ad75-cb918d817067

Public Version Date

October 09, 2020

Public Version Number

4

DI Record Publish Date

August 30, 2015

Additional Identifiers

Package DI Number

00885554007640

Quantity per Package

1

Contains DI Package

03596010026286

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

EA

"SMITH & NEPHEW, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10651
2 A medical device with a moderate to high risk that requires special controls. 35590
3 A medical device with high risk that requires premarket approval 351