HemCon® OneStop™ Vascular - The OneStop™ Vascular is a wound dressing - TRICOL BIOMEDICAL, INC.

Duns Number:080240553

Device Description: The OneStop™ Vascular is a wound dressing manufactured from chitosan. When applied directl

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More Product Details

Catalog Number

1102

Brand Name

HemCon® OneStop™ Vascular

Version/Model Number

1

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"

Yes

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

K150916,K150916,K150916

Product Code Details

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Device Record Status

Public Device Record Key

79b811d1-0a8b-495c-bd76-a043ac13c9be

Public Version Date

March 10, 2021

Public Version Number

2

DI Record Publish Date

September 22, 2020

Additional Identifiers

Package DI Number

20870053000326

Quantity per Package

10

Contains DI Package

00870053000322

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"TRICOL BIOMEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
U Unclassified 6