N/A - Laparoscopic Appendectomy Kit - ETHICON ENDO-SURGERY, LLC

Duns Number:044606982

Device Description: Laparoscopic Appendectomy Kit

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More Product Details

Catalog Number

GNRL14

Brand Name

N/A

Version/Model Number

GNRL14

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

-

Product Code Name

-

Device Record Status

Public Device Record Key

5c57048f-d320-418e-8f53-185ffd95dd7f

Public Version Date

October 16, 2019

Public Version Number

3

DI Record Publish Date

June 06, 2017

Additional Identifiers

Package DI Number

20705036015946

Quantity per Package

6

Contains DI Package

10705036015949

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX

"ETHICON ENDO-SURGERY, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6
2 A medical device with a moderate to high risk that requires special controls. 27
U Unclassified 6