HemCon® ChitoPulse™, 15 inch - ChitoPulse™ is a compression device incorporating - TRICOL BIOMEDICAL, INC.

Duns Number:080240553

Device Description: ChitoPulse™ is a compression device incorporating a hemostatic chitosan patch that, when p

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More Product Details

Catalog Number

1097

Brand Name

HemCon® ChitoPulse™, 15 inch

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

-

Product Code Details

Product Code

DXC

Product Code Name

Clamp, Vascular

Device Record Status

Public Device Record Key

6af5f99e-4f1b-41bc-9c43-5998f2dd91b5

Public Version Date

August 26, 2020

Public Version Number

1

DI Record Publish Date

August 18, 2020

Additional Identifiers

Package DI Number

20870053000166

Quantity per Package

5

Contains DI Package

00870053000162

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