FDA.reportPublic FDA data

D-Stat® Radial topical hemostat

Primary DI
M20635011
Brand
D-Stat® Radial topical hemostat
Company
Vascular Solutions, Inc.
Model
3501
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
OTC
false
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
M20635011PackageHIBCC10Not in Commercial Distribution
M20635010PrimaryHIBCC0

Sterilization Methods#

Method table
Method

Contacts#

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

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 DIBrandModelCatalogPublished
M2067200V0VSI Micro-Introducer Kit7200V2016-09-05
M2067214V0VSI Micro-Introducer Kit7214V2016-09-05
M2067244V0VSI Micro-Introducer Kit7244V2016-09-05
M2067245V0VSI Micro-Introducer Kit7245V2016-09-05
M2067246V0VSI Micro-Introducer Kit7246V2016-09-05
M2067247V0VSI Micro-Introducer Kit7247V2016-09-05
M2067248V0VSI Micro-Introducer Kit7248V2016-09-05
M2067249V0VSI Micro-Introducer Kit7249V2016-09-05
M2067250V0VSI Micro-Introducer Kit7250V2016-09-05
M2067253V0VSI Micro-Introducer Kit7253V2016-09-05
M2067254V0VSI Micro-Introducer Kit7254V2016-09-05
M2067255V0VSI Micro-Introducer Kit7255V2016-09-05
M2067256V0VSI Micro-Introducer Kit7256V2016-09-05
M2067260V0VSI Micro-Introducer Kit7260V2016-09-05
M2067261V0VSI Micro-Introducer Kit7261V2016-09-05
M2067262V0VSI Micro-Introducer Kit7262V2016-09-05
M2067263V0VSI Micro-Introducer Kit7263V2016-09-05
M2067264V0VSI Micro-Introducer Kit7264V2016-09-05
M2067265V0VSI Micro-Introducer Kit7265V2016-09-05
M2067266V0VSI Micro-Introducer Kit7266V2016-09-05

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
M20630060D-Stat® Dry 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