Monosof - Monofilament Nylon, P-24, 1x Black Strand - Covidien LP

Duns Number:058614483

Device Description: Monofilament Nylon, P-24, 1x Black Strand

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More Product Details

Catalog Number

SN5662GMDL

Brand Name

Monosof

Version/Model Number

SN5662GMDL

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

K900531,K900531

Product Code Details

Product Code

GAR

Product Code Name

Suture, nonabsorbable, synthetic, polyamide

Device Record Status

Public Device Record Key

af05e5ff-fb67-43e9-9dbf-5000d71a317e

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

20884521212326

Quantity per Package

12

Contains DI Package

10884521212329

Package Discontinue Date

-

Package Status

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