FDA.reportPublic FDA data

WoundClot Hemostatic Gauze

Primary DI
07290016339307
Brand
WoundClot Hemostatic Gauze
Company
CORE SCIENTIFIC CREATIONS LTD
Model
" 3"" X 39"" OTC FDA"
Catalog number
101581901
Device description
WoundClot is a soluble dressing, based on cellulosic structure. In contact with liquids it forms absorbent gel which adheres to the wound surface to control bleeding.WoundClot is intended to be used as a topical dressing for minor skin surface bleeding wounds such as minor cuts and minor abrasions.
Published
2021-09-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QSYHemostatic Wound Dressing Without Thrombin Or Other Biologics

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160679000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160679000WoundClot9Core Scientific Creation , Ltd.2016-08-08QSY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290016339304PackageGS110Not in Commercial Distribution
07290016339307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001633930417290016339304
07290016339307072900163393077290016339307

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

Contacts#

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

Regulatory Flags#

DUNS number
600041570
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
07290016339413WoundClot Hemostatic Gauze" 3""X23.6"" OTC FDA"1015869012021-09-01

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