Veriset - Hemostatic Patch - Covidien LP

Duns Number:058614483

Device Description: Hemostatic Patch

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More Product Details

Catalog Number

HP0204E

Brand Name

Veriset

Version/Model Number

HP0204E

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 15, 2016

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

-

Product Code Details

Product Code

LMG

Product Code Name

Agent, Absorbable Hemostatic, Non-Collagen Based

Device Record Status

Public Device Record Key

4f537377-78e8-434b-b75d-fa0f1764476f

Public Version Date

August 09, 2019

Public Version Number

6

DI Record Publish Date

April 15, 2016

Additional Identifiers

Package DI Number

10884521082533

Quantity per Package

6

Contains DI Package

20884521082530

Package Discontinue Date

April 15, 2016

Package Status

Not in Commercial Distribution

Package Type

CS

"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