Maxon - Monofilament Absorbable Suture - Covidien LP

Duns Number:058614483

Device Description: Monofilament Absorbable Suture

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More Product Details

Catalog Number

-

Brand Name

Maxon

Version/Model Number

SMM-5516

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

K990951,K990951

Product Code Details

Product Code

GAM

Product Code Name

SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Device Record Status

Public Device Record Key

f9e78cc7-e425-45de-aa5a-5339717dfdaa

Public Version Date

February 21, 2022

Public Version Number

6

DI Record Publish Date

September 02, 2015

Additional Identifiers

Package DI Number

20884523004707

Quantity per Package

36

Contains DI Package

10884523004700

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