ULTRAPRO COMFORT PLUG - Partially Absorbable Hernia Repair Device - Johnson & Johnson International Inc.

Duns Number:372587696

Device Description: Partially Absorbable Hernia Repair Device

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More Product Details

Catalog Number

UPLUG556

Brand Name

ULTRAPRO COMFORT PLUG

Version/Model Number

UPLUG556

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 22, 2020

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

66fa0f38-2acd-40b1-9c60-491cc9735e65

Public Version Date

June 10, 2022

Public Version Number

8

DI Record Publish Date

September 01, 2015

Additional Identifiers

Package DI Number

20705031233291

Quantity per Package

6

Contains DI Package

10705031233294

Package Discontinue Date

May 22, 2020

Package Status

Not in Commercial Distribution

Package Type

BOX

"JOHNSON & JOHNSON INTERNATIONAL INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 84