PROCEED - PROCEED Surgical Mesh 30.5 cm x 30.5 cm (12" x - Johnson & Johnson International Inc.

Duns Number:372587696

Device Description: PROCEED Surgical Mesh 30.5 cm x 30.5 cm (12" x 12") Square

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More Product Details

Catalog Number

PCDL1

Brand Name

PROCEED

Version/Model Number

PCDL1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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

K060713

Product Code Details

Product Code

FTL

Product Code Name

Mesh, surgical, polymeric

Device Record Status

Public Device Record Key

64d6502a-7028-4a62-8f72-6b7c5ea9630a

Public Version Date

June 10, 2022

Public Version Number

8

DI Record Publish Date

September 23, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"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