Steel - Monofilament Stainless Steel - Covidien LP

Duns Number:058614483

Device Description: Monofilament Stainless Steel

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More Product Details

Catalog Number

W-23G

Brand Name

Steel

Version/Model Number

W-23G

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

K955723,K955723

Product Code Details

Product Code

GAQ

Product Code Name

SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE

Device Record Status

Public Device Record Key

e044a662-80c2-4728-968b-fdbbd11a430d

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

September 02, 2015

Additional Identifiers

Package DI Number

20884521163758

Quantity per Package

12

Contains DI Package

10884521163751

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