Powered Multifire Endo GIA - Powered Multifire Endo GIA - Covidien LP

Duns Number:058614483

Device Description: Powered Multifire Endo GIA

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More Product Details

Catalog Number

-

Brand Name

Powered Multifire Endo GIA

Version/Model Number

030316L

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 02, 2019

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

GDW

Product Code Name

STAPLE, IMPLANTABLE

Device Record Status

Public Device Record Key

fdc95990-f7c2-4bef-8996-293b81d5d1cc

Public Version Date

September 09, 2022

Public Version Number

7

DI Record Publish Date

August 28, 2015

Additional Identifiers

Package DI Number

20884523003854

Quantity per Package

6

Contains DI Package

10884523003857

Package Discontinue Date

October 02, 2019

Package Status

Not 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