FDA.reportPublic FDA data

D-Stat® Dry Clear topical hemostat

Primary DI
M20630060
Brand
D-Stat® Dry Clear topical hemostat
Company
Vascular Solutions, Inc.
Model
3006
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
QSXHemostatic Wound Dressing With Thrombin Or Other Biologics

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QSXHemostatic Wound Dressing With Thrombin Or Other BiologicsUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M20630061PackageHIBCC10Not in Commercial Distribution
M20630060PrimaryHIBCC0

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
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M20655660TrapLiner™ catheter55662017-02-07
M20655680TrapLiner™ catheter55682017-02-07
M20655670TrapLiner™ catheter55672017-02-07
M20655690GuideLiner® V3 catheter55692016-09-05
M20655700GuideLiner® V3 catheter55702016-09-05
M20655710GuideLiner® V3 catheter55712016-09-05
M20655720GuideLiner® V3 catheter55722016-09-05
M20655730GuideLiner® V3 catheter55732016-09-05
M20656210Turnpike® Gold catheter56212016-09-05
M20656220Turnpike® Gold catheter56222016-09-05
M20656380Turnpike® LP catheter56382016-09-05
M20656390Turnpike® LP catheter56392016-09-05
M20656400Turnpike® Spiral catheter56402016-09-05
M20656410Turnpike® Spiral catheter56412016-09-05
M20656420Turnpike® catheter56422016-09-05
M20656430Turnpike® catheter56432016-09-05
M20654700GuideLiner® Navigation™ catheter54702016-09-05
M20654710GuideLiner® Navigation™ catheter54712016-09-05
M20654720GuideLiner® Navigation™ catheter54722016-09-05
M20654730GuideLiner® Navigation™ catheter54732016-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10841156105587D-STATTELEFLEX INCORPORATEDQSX2022-12-15
20841156105584D-STATTELEFLEX INCORPORATEDQSX2022-12-15
10841156102005D-STATTELEFLEX INCORPORATEDQSX2022-12-08
30841156102009D-STATTELEFLEX INCORPORATEDQSX2022-12-08
10841156105624D-STATTELEFLEX INCORPORATEDQSX2022-06-08
20841156105621D-STATTELEFLEX INCORPORATEDQSX2022-06-08
10841156105570D-STATTELEFLEX INCORPORATEDQSX2022-05-25
20841156105577D-STATTELEFLEX INCORPORATEDQSX2022-05-25
10841156106539D-STATTELEFLEX INCORPORATEDQSX2020-07-31
20841156106536D-STATTELEFLEX INCORPORATEDQSX2020-07-31
10841156101749D-STATTELEFLEX INCORPORATEDQSX2019-10-18
30841156101743D-STATTELEFLEX INCORPORATEDQSX2019-10-18
M20630050D-Stat® Dry Silver Clear topical hemostatVascular Solutions, Inc.QSX2016-09-15
M20630100D-Stat® 2 Dry topical hemostatVascular Solutions, Inc.QSX2016-09-15
M20635010D-Stat® Radial topical hemostatVascular Solutions, Inc.QSX2016-09-15
M20630051D-Stat® Dry Silver Clear topical hemostatVascular Solutions, Inc.QSX2016-09-15
M20630061D-Stat® Dry Clear topical hemostatVascular Solutions, Inc.QSX2016-09-15
M20630101D-Stat® 2 Dry topical hemostatVascular Solutions, Inc.QSX2016-09-15
M20635011D-Stat® Radial topical hemostatVascular Solutions, Inc.QSX2016-09-15