ASSUFIL MONOFILAMENTO - ASSUT EUROPE SPA

Duns Number:654747567

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More Product Details

Catalog Number

-

Brand Name

ASSUFIL MONOFILAMENTO

Version/Model Number

04F.L.232DN/DS/20

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K150553

Product Code Details

Product Code

NEW

Product Code Name

Suture, Surgical, Absorbable, Polydioxanone

Device Record Status

Public Device Record Key

f0be0cd1-8e17-4a7e-a288-c65271dc9d4b

Public Version Date

June 21, 2022

Public Version Number

1

DI Record Publish Date

June 13, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ASSUT EUROPE SPA" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 54