Thrombi-Gel® thrombin/gelatin foam hemostat - Vascular Solutions, Inc.

Duns Number:008999906

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Thrombi-Gel® thrombin/gelatin foam hemostat

Version/Model Number

0907

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 18, 2022

Issuing Agency

In HIBCC

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

FRO

Product Code Name

Dressing, Wound, Drug

Device Record Status

Public Device Record Key

143b3750-437e-4441-954f-b211247c6288

Public Version Date

February 18, 2022

Public Version Number

6

DI Record Publish Date

September 15, 2016

Additional Identifiers

Package DI Number

M20609071

Quantity per Package

10

Contains DI Package

M20609070

Package Discontinue Date

February 18, 2022

Package Status

Not in Commercial Distribution

Package Type

Box

"VASCULAR SOLUTIONS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6
2 A medical device with a moderate to high risk that requires special controls. 238
U Unclassified 12