FDA.reportPublic FDA data

WoundClot Hemostatic Gauze

Primary DI
17290016339397
Brand
WoundClot Hemostatic Gauze
Company
CORE SCIENTIFIC CREATIONS LTD
Model
2"X2" OTC FDA
Catalog number
101555901
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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
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
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
17290016339397PackageGS110In Commercial Distribution
07290016339390PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001633939717290016339397
07290016339390072900163393907290016339390

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

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