FDA.reportPublic FDA data

Thrombix® Hemostasis Patch topical hemostat

Primary DI
M20631010
Brand
Thrombix® Hemostasis Patch topical hemostat
Company
Vascular Solutions, Inc.
Model
3101
Published
2016-09-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M20631011PackageHIBCC25Not in Commercial Distribution
M20631010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Thrombin haemostatic agent, non-antimicrobialA 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.

Contacts#

Phone, Email table
PhoneEmail
888-240-6001customerservice@vasc.com

Regulatory Flags#

DUNS number
008999906
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M20679600VSI StraitSet™ micro-introducer kit79602018-08-09
M20679610VSI StraitSet™ micro-introducer kit79612018-08-09
M20679620VSI StraitSet™ micro-introducer kit79602018-08-09
M20679640VSI StraitSet™ micro-introducer kit79602018-08-09
M20679650VSI StraitSet™ micro-introducer kit79612018-08-09
M20679710VSI StraitSet™ micro-introducer kit79612018-08-09
M206780500SmartNeedle® vascular access system780502016-09-06
M206780600SmartNeedle® vascular access system780602016-09-06
M206780300SmartNeedle® vascular access system780302016-09-05
M206780400SmartNeedle® vascular access system780402016-09-06
M206720000SmartNeedle® monitor720002016-09-23
M20630100D-Stat® 2 Dry topical hemostat30102016-09-15
M20681500Teirstein Edge™ device organizer81502016-09-05
M20681510Angio Assist™ docking station81512016-09-05
M20673710Axis™ guidewire73712016-09-05
M20673720Axis™ guidewire73722016-09-05
M20674720VSI Tru-Torque™ guidewire74722016-09-05
M20674730VSI Tru-Torque™ guidewire74732016-09-05
M20674790Amplatz SST™ guidewire74792016-09-05
M20674820Amplatz SST™ guidewire74822016-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00714196111050DermaRite Medical DermaHoney Medical Grade Honey 0.5 oz TubeSion Brands LLCFRO2026-06-01
00714196111074DermaRite Medical DermaHoney Medical Grade Honey 1.75 oz TubeSion Brands LLCFRO2026-06-01
01714196222045DermaRite Medical DermaHoney Tulle Non Border Honey Gauze 4x4Sion Brands LLCFRO2026-06-01
01714196333048DermaRite Medical DermaHoney Border Medical Grade Honey Sheet 4x4Sion Brands LLCFRO2026-06-01
08717249680130DermaRite Medical L-Mesitran 0.5 oz TubeSion Brands LLCFRO2026-06-01
08717249680147DermaRite Medical L-Mesitran 1.75 oz TubeSion Brands LLCFRO2026-06-01
00850087488259CeeportCEEPORT INC.FRO2026-05-29
00850087488266CeeportCEEPORT INC.FRO2026-05-29
10080196415397MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10888277415386MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10888277415393MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10888277677289MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10888277677296MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
00850087488006CeeportCEEPORT INC.FRO2026-05-22
10197344175994MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-20
10840330706688ProCureTwin Med, LLCFRO2026-05-04
09551012610035ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
09551012610196ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
09551012610363ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
09551012610370ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
10192253046403KendallCardinal Health 200, LLCFRO2026-03-25
10192253046519KendallCardinal Health 200, LLCFRO2026-03-25
09120073781536GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
09120073781543GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
09120073781550GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
09120073781567GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
09120073781574GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
10197344169412MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-12-05
10197344169443MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-12-05
10197344169467MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-11-07