LiquiBand Exceed - 2-Octyl Cyanoacrylate - Covidien LP

Duns Number:058614483

Device Description: 2-Octyl Cyanoacrylate

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More Product Details

Catalog Number

LX6

Brand Name

LiquiBand Exceed

Version/Model Number

LX6

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

K151182,K151182,K151182

Product Code Details

Product Code

MPN

Product Code Name

Tissue adhesive for the topical approximation of skin

Device Record Status

Public Device Record Key

d1947b51-1461-4a95-8cf8-df1a4edce39d

Public Version Date

November 23, 2018

Public Version Number

4

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

20884521543437

Quantity per Package

6

Contains DI Package

10884521543430

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK_OR_INNER_PACK

"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