FDA.reportPublic FDA data

WoundClot Hemostatic Gauze

Primary DI
17290016339144
Brand
WoundClot Hemostatic Gauze
Company
CORE SCIENTIFIC CREATIONS LTD
Model
3"X8" EMS FDA
Catalog number
101482901
Device description
WoundClot hemostatic gauz, based on cellulosic structure. In contact with liquids it forms absorbent gel which adheres to the wound surface to control bleeding. WoundClot is hemostatic gauze for emergency and therapeutic use in the control of bleeding from the skin and other surface wounds where temporary control of bleeding is required, including traumatic bleeding.
Published
2021-09-01
Public version status
New
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
FRODressing, Wound, Drug
QSYHemostatic Wound Dressing Without Thrombin Or Other Biologics

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU
QSYHemostatic Wound Dressing Without Thrombin Or Other BiologicsUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140573000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140573000WOUNDCLOT HEMOSTATIC GAUZECore Scientific , Ltd.2014-11-24QSY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290016339144PackageGS110In Commercial Distribution
07290016339147PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001633914417290016339144
07290016339147072900163391477290016339147

GMDN Terms#

Term, Definition table
TermDefinition
Plant polysaccharide haemostatic agent, bioabsorbableA bioabsorbable device derived from plant polysaccharides (e.g., starch, agar derivative, cellulose-derived) intended for topical application to a traumatic wound (e.g., abrasion, laceration, cut), ulcer, and/or surgical wound to facilitate local haemostasis; it is not dedicated to bone haemostasis. It is available in various forms (e.g., liquid, spray, foam, particles, foam pad/sponge, bandage strip, gauze pad) that can be applied directly to the wound where it remains to be absorbed by the body; it does not contain an antimicrobial agent. It may be used in combination with supplemental agents (e.g., vitamin K-dependent coagulation factors). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature41 Degrees Fahrenheit95 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+97237359555questions@woundclot.com

Regulatory Flags#

DUNS number
600041570
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
07290016339307WoundClot Hemostatic Gauze" 3"" X 39"" OTC FDA"1015819012021-09-01
07290016339901BleedBloc Hemostatic Gauze"Double Pack 2"" X 2"" (5cm X 5cm) US"1050559022023-09-01
07290016339864BleedBloc Hemostatic Gauze"4"" X 4"" (10cm X 10cm) US"1050119012023-09-01
07290016339871BleedBloc Hemostatic Gauze"3"" X 8"" (8cm X 20cm) US"1050829012023-09-01
07290016339888BleedBloc Hemostatic Gauze"3"" X 24"" (8cm X 60cm) US"1050869012023-09-01
07290016339895BleedBloc Hemostatic Gauze"3"" X 39"" (8cm X 100cm) US"1050819012023-09-01
17290016339908BleedBloc Hemostatic GauzeDouble Pack 2" X 2" (5cm X 5cm) US1050559022023-09-01
07290016339086WoundClot Hemostatic Gauze"4""X4"" FDA"1010119012021-09-01
07290016339116WoundClot Hemostatic Gauze" 3""X39"" PreHospital FDA"1011819012021-09-01
07290016339123WoundClot Hemostatic Gauze"3""X8"" PreHospital FDA"1011829012021-09-01
07290016339130WoundClot Hemostatic Gauze" 3""X39"" EMS FDA"1014819012021-09-01
07290016339147WoundClot Hemostatic Gauze" 3""X8"" EMS FDA"1014829012021-09-01
07290016339178WoundClot Hemostatic Gauze" 4""X4"" PreHospital FDA"1011119012021-09-01
07290016339185WoundClot Hemostatic Gauze"4""X4"" EMS FDA"1014119012021-09-01
07290016339260WoundClot Hemostatic Gauze"8""X12"" PreHospital FDA"1011239012021-09-01
07290016339277WoundClot Hemostatic Gauze" 8""X12"" EMS FDA"1014239012021-09-01
07290016339369WoundClot Hemostatic Gauze"TWIN PACK 2""X2"" FDA"1010559022021-09-01
07290016339383WoundClot Hemostatic Gauze" 8""X12"" OTC FDA"1015239012021-09-01
07290016339390WoundClot Hemostatic Gauze"2""X2"" OTC FDA"1015559012021-09-01
07290016339406WoundClot Hemostatic Gauze"3""X8"" OTC FDA"1015829012021-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50192253067901ASOCardinal Health 200, LLCFRO2026-06-03
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
00860007891168TRAUMAGEL®Cresilon, Inc.QSY2026-06-01
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
00017276241709Rapid SealAso LLCQSY2026-05-27
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