D-STAT

Primary DI
30841156102009
Brand
D-STAT
Company
TELEFLEX INCORPORATED
Model
IPN913524
Catalog number
3001
Device description
D-Stat Dry
Published
2022-12-08
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

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061219000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061219000D-STAT DRY HEMOSTATIC BANDAGEVascular Solutions, Inc.2006-10-06QSX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30841156102009PackageGS110In Commercial Distribution
10841156102005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3084115610200930841156102009
1084115610200510841156102005

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
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
10801902222920ARROWIPN931154CV-15703-E2026-05-20
10801902222937ARROWIPN931155CV-158022026-05-20
10801902222944ARROWIPN931156CV-16702-E2026-05-20
10841495149792QUIKCLOT6366362026-05-18
10841156105907VSIIPN00174679602020-01-27
10841156105914VSIIPN00174979612020-01-27
10841156105921VSIIPN00175279622020-02-06
10841156105938VSIIPN00175679642020-01-27
10841156105945VSIIPN00175979652020-02-06
10841156105952VSIIPN00176379712020-01-27
14026704942456RUSCH221800-000160221800-0001602026-05-15
14026704942463RUSCH221800-000180221800-0001802026-05-15
14026704942470RUSCH221800-000200221800-0002002026-05-15
14026704942487RUSCH221800-000220221800-0002202026-05-15
14026704942494RUSCH221800-000240221800-0002402026-05-15
14026704942500RUSCH221800-000120221800-0001202026-05-15
14026704942517RUSCH221800-000140221800-0001402026-05-15
10801902226096ARROWIPNB00593ASK-15703-BFL2026-05-14
10801902226102ARROWIPNB00594ASK-12703-BFL2026-05-14
14026704921321WECKIPN928663HOL2LG2025-08-25

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
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
M20635011D-Stat® Radial topical hemostatVascular Solutions, Inc.QSX2016-09-15