E-PACK - E-Pack Procedure Kit - ETHICON INC.

Duns Number:002144145

Device Description: E-Pack Procedure Kit

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More Product Details

Catalog Number

9920E

Brand Name

E-PACK

Version/Model Number

9920E

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 22, 2019

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

FTL

Product Code Name

Mesh, surgical, polymeric

Device Record Status

Public Device Record Key

0dd2ee5e-385e-4857-99a2-fb572eae09dc

Public Version Date

June 17, 2022

Public Version Number

5

DI Record Publish Date

March 02, 2018

Additional Identifiers

Package DI Number

30705031245505

Quantity per Package

5

Contains DI Package

20705031245508

Package Discontinue Date

August 22, 2019

Package Status

Not in Commercial Distribution

Package Type

BOX

"ETHICON INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 29
2 A medical device with a moderate to high risk that requires special controls. 1128
3 A medical device with high risk that requires premarket approval 4
U Unclassified 1