Home GUDID M20630101 D-Stat® 2 Dry topical hemostat
Primary DI M20630101
Brand D-Stat® 2 Dry topical hemostat
Company Vascular Solutions, Inc.
Model 3010
Published 2016-09-15
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name QSX Hemostatic Wound Dressing With Thrombin Or Other Biologics
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QSX Hemostatic Wound Dressing With Thrombin Or Other Biologics Unknown U
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M20630101 Package HIBCC 10 In Commercial Distribution M20630100 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Thrombin haemostatic agent, non-antimicrobial A non-bioabsorbable device containing animal-derived thrombin, without an antimicrobial agent, intended to be used by a healthcare professional for topical application to a surgical wound (e.g., during percutaneous vascular access), to facilitate local haemostasis primarily through thrombin activation of blood clotting mechanisms. It is typically available in the form of bandage, pad, or sponge that can be applied directly to the wound. This is a single-use device.
Regulatory Flags# DUNS number 008999906 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published M20679600 VSI StraitSet™ micro-introducer kit 7960 2018-08-09 M20679610 VSI StraitSet™ micro-introducer kit 7961 2018-08-09 M20679620 VSI StraitSet™ micro-introducer kit 7960 2018-08-09 M20679640 VSI StraitSet™ micro-introducer kit 7960 2018-08-09 M20679650 VSI StraitSet™ micro-introducer kit 7961 2018-08-09 M20679710 VSI StraitSet™ micro-introducer kit 7961 2018-08-09 M206780500 SmartNeedle® vascular access system 78050 2016-09-06 M206780600 SmartNeedle® vascular access system 78060 2016-09-06 M206780300 SmartNeedle® vascular access system 78030 2016-09-05 M206780400 SmartNeedle® vascular access system 78040 2016-09-06 M206720000 SmartNeedle® monitor 72000 2016-09-23 M20631010 Thrombix® Hemostasis Patch topical hemostat 3101 2016-09-15 M20630100 D-Stat® 2 Dry topical hemostat 3010 2016-09-15 M20681500 Teirstein Edge™ device organizer 8150 2016-09-05 M20681510 Angio Assist™ docking station 8151 2016-09-05 M20673710 Axis™ guidewire 7371 2016-09-05 M20673720 Axis™ guidewire 7372 2016-09-05 M20674720 VSI Tru-Torque™ guidewire 7472 2016-09-05 M20674730 VSI Tru-Torque™ guidewire 7473 2016-09-05 M20674790 Amplatz SST™ guidewire 7479 2016-09-05
Other Devices Sharing Product Codes# 
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