Permacol - Surgical Implant - SOFRADIM PRODUCTION

Duns Number:576342646

Device Description: Surgical Implant

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More Product Details

Catalog Number

-

Brand Name

Permacol

Version/Model Number

P100510

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

K120605

Product Code Details

Product Code

FTM

Product Code Name

Mesh, surgical

Device Record Status

Public Device Record Key

347af7e2-b92a-406e-a8fe-322a20a44596

Public Version Date

August 12, 2022

Public Version Number

6

DI Record Publish Date

October 16, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SOFRADIM PRODUCTION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 239