Steel - Monofilament Stainless Steel - Covidien LP

Duns Number:058614483

Device Description: Monofilament Stainless Steel

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More Product Details

Catalog Number

-

Brand Name

Steel

Version/Model Number

88862497-89

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

09b24a6a-2c57-4bfc-a947-1ecd10c7807a

Public Version Date

July 22, 2022

Public Version Number

7

DI Record Publish Date

August 31, 2015

Additional Identifiers

Package DI Number

20884521102740

Quantity per Package

12

Contains DI Package

10884521102743

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