Home GUDID 17290016339120 WoundClot Hemostatic Gauze
Primary DI 17290016339120
Brand WoundClot Hemostatic Gauze
Company CORE SCIENTIFIC CREATIONS LTD
Model 3"X8" PreHospital FDA
Catalog number 101182901
Device description WoundClot hemostatic gauze is 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 Product Codes# Code, Name table Code Name FRO Dressing, Wound, Drug QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FRO Dressing, Wound, Drug Unknown U QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics Unknown U
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 17290016339120 Package GS1 10 In Commercial Distribution 07290016339123 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 17290016339120 17290016339120 07290016339123 07290016339123 7290016339123
GMDN Terms# Term, Definition table Term Definition Plant polysaccharide haemostatic agent, bioabsorbable A 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 Type Low High Condition Storage Environment Temperature 41 Degrees Fahrenheit 95 Degrees Fahrenheit
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 DI Brand Model Catalog Published 07290016339307 WoundClot Hemostatic Gauze " 3"" X 39"" OTC FDA" 101581901 2021-09-01 07290016339901 BleedBloc Hemostatic Gauze "Double Pack 2"" X 2"" (5cm X 5cm) US" 105055902 2023-09-01 07290016339864 BleedBloc Hemostatic Gauze "4"" X 4"" (10cm X 10cm) US" 105011901 2023-09-01 07290016339871 BleedBloc Hemostatic Gauze "3"" X 8"" (8cm X 20cm) US" 105082901 2023-09-01 07290016339888 BleedBloc Hemostatic Gauze "3"" X 24"" (8cm X 60cm) US" 105086901 2023-09-01 07290016339895 BleedBloc Hemostatic Gauze "3"" X 39"" (8cm X 100cm) US" 105081901 2023-09-01 17290016339908 BleedBloc Hemostatic Gauze Double Pack 2" X 2" (5cm X 5cm) US 105055902 2023-09-01 07290016339086 WoundClot Hemostatic Gauze "4""X4"" FDA" 101011901 2021-09-01 07290016339116 WoundClot Hemostatic Gauze " 3""X39"" PreHospital FDA" 101181901 2021-09-01 07290016339123 WoundClot Hemostatic Gauze "3""X8"" PreHospital FDA" 101182901 2021-09-01 07290016339130 WoundClot Hemostatic Gauze " 3""X39"" EMS FDA" 101481901 2021-09-01 07290016339147 WoundClot Hemostatic Gauze " 3""X8"" EMS FDA" 101482901 2021-09-01 07290016339178 WoundClot Hemostatic Gauze " 4""X4"" PreHospital FDA" 101111901 2021-09-01 07290016339185 WoundClot Hemostatic Gauze "4""X4"" EMS FDA" 101411901 2021-09-01 07290016339260 WoundClot Hemostatic Gauze "8""X12"" PreHospital FDA" 101123901 2021-09-01 07290016339277 WoundClot Hemostatic Gauze " 8""X12"" EMS FDA" 101423901 2021-09-01 07290016339369 WoundClot Hemostatic Gauze "TWIN PACK 2""X2"" FDA" 101055902 2021-09-01 07290016339383 WoundClot Hemostatic Gauze " 8""X12"" OTC FDA" 101523901 2021-09-01 07290016339390 WoundClot Hemostatic Gauze "2""X2"" OTC FDA" 101555901 2021-09-01 07290016339406 WoundClot Hemostatic Gauze "3""X8"" OTC FDA" 101582901 2021-09-01
Other Devices Sharing Product Codes# 
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