Endo Clip III - Clip Applier with Clip Logic Technology - Covidien LP

Duns Number:058614483

Device Description: Clip Applier with Clip Logic Technology

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More Product Details

Catalog Number

-

Brand Name

Endo Clip III

Version/Model Number

176630B

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

K071406,K071406

Product Code Details

Product Code

GDO

Product Code Name

Applier, surgical, clip

Device Record Status

Public Device Record Key

94d95e63-31c7-41d2-b642-43e410cf491b

Public Version Date

November 19, 2021

Public Version Number

3

DI Record Publish Date

February 14, 2019

Additional Identifiers

Package DI Number

20884521047263

Quantity per Package

6

Contains DI Package

10884521047266

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