DAR - Extendable Extension Tube - Covidien LP

Duns Number:058614483

Device Description: Extendable Extension Tube

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More Product Details

Catalog Number

-

Brand Name

DAR

Version/Model Number

332U5663

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

Yes

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

BZA

Product Code Name

CONNECTOR, AIRWAY (EXTENSION)

Device Record Status

Public Device Record Key

6656135e-3c6c-4fdd-a1be-f03abb59bc3a

Public Version Date

April 08, 2021

Public Version Number

7

DI Record Publish Date

August 19, 2018

Additional Identifiers

Package DI Number

20884522032756

Quantity per Package

25

Contains DI Package

10884522032759

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"COVIDIEN LP" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 132
2 A medical device with a moderate to high risk that requires special controls. 8540
3 A medical device with high risk that requires premarket approval 202
U Unclassified 40