Sofsilk - Wax Coated Braided Silk - Covidien LP

Duns Number:058614483

Device Description: Wax Coated Braided Silk

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More Product Details

Catalog Number

-

Brand Name

Sofsilk

Version/Model Number

VS671-2

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 12, 2021

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

K981128,K981128

Product Code Details

Product Code

GAP

Product Code Name

SUTURE, NONABSORBABLE, SILK

Device Record Status

Public Device Record Key

3d170cd2-b701-42e2-a111-ae6a3f009328

Public Version Date

May 03, 2022

Public Version Number

4

DI Record Publish Date

July 19, 2020

Additional Identifiers

Package DI Number

20884521758022

Quantity per Package

36

Contains DI Package

10884521758025

Package Discontinue Date

February 12, 2021

Package Status

Not in Commercial Distribution

Package Type

CASE

"COVIDIEN LP" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 132
2 A medical device with a moderate to high risk that requires special controls. 8540
3 A medical device with high risk that requires premarket approval 202
U Unclassified 40