HemCon® OneStop® Vascular, 2in x 2in 1103

GUDID 20870053000401

The OneStop™ Dressing is a wound dressing manufactured from chitosan. When applied directly to the wound, the OneStop™ dressing controls bleeding. The OneStop™ dressing offers an antibacterial barrier against a wide range of gram positive and gram negative organisms, including antibiotic resistant Staphylococcus aureus (MRSA), Enterococcus faecalis (VRE) and Acinetobacter baumannii. Only single strains of most species mentioned have been studied.

TRICOL BIOMEDICAL, INC.

Chitosan haemostatic agent, professional
Primary Device ID20870053000401
NIH Device Record Key9f964485-b128-4600-8f7c-405f9c7c6645
Commercial Distribution StatusIn Commercial Distribution
Brand NameHemCon® OneStop® Vascular, 2in x 2in
Version Model Number1
Catalog Number1103
Company DUNS080240553
Company NameTRICOL BIOMEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone9712231000
Emailsales@tricolbiomedical.com
Phone9712231000
Emailsales@tricolbiomedical.com
Phone9712231000
Emailsales@tricolbiomedical.com
Phone9712231000
Emailsales@tricolbiomedical.com
Phone9712231000
Emailsales@tricolbiomedical.com
Phone9712231000
Emailsales@tricolbiomedical.com
Phone9712231000
Emailsales@tricolbiomedical.com
Phone9712231000
Emailsales@tricolbiomedical.com
Phone9712231000
Emailsales@tricolbiomedical.com
Phone9712231000
Emailsales@tricolbiomedical.com
Phone9712231000
Emailsales@tricolbiomedical.com
Phone9712231000
Emailsales@tricolbiomedical.com
Phone9712231000
Emailsales@tricolbiomedical.com
Phone9712231000
Emailsales@tricolbiomedical.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 11 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 11 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 11 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 11 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 11 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 11 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 11 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 11 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 11 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 11 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 11 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 11 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 11 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 11 Degrees Celsius and 26 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100870053000407 [Primary]
GS120870053000401 [Package]
Contains: 00870053000407
Package: Box [10 Units]
In Commercial Distribution
GS150870053000402 [Package]
Package: 10 [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRODressing, Wound, Drug

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-04-13
Device Publish Date2022-04-05

Devices Manufactured by TRICOL BIOMEDICAL, INC.

20870053000562 - ChitoGauzeXR PRO, 3in x 4yds2024-06-07 HemCon ChitoGauzeXR PRO is a hemostatic dressing for the external, temporary control of severely bleeding wounds.
20870053000401 - HemCon® OneStop® Vascular, 2in x 2in2022-04-13The OneStop™ Dressing is a wound dressing manufactured from chitosan. When applied directly to the wound, the OneStop™ dressing controls bleeding. The OneStop™ dressing offers an antibacterial barrier against a wide range of gram positive and gram negative organisms, including antibiotic resistant Staphylococcus aureus (MRSA), Enterococcus faecalis (VRE) and Acinetobacter baumannii. Only single strains of most species mentioned have been studied.
20870053000401 - HemCon® OneStop® Vascular, 2in x 2in2022-04-13 The OneStop™ Dressing is a wound dressing manufactured from chitosan. When applied directly to the wound, the OneStop™ dress
20870053000418 - HemCon® OneStop® Vascular, 1.5in x 1.5in, Pre-Slit2022-04-13 The OneStop™ Vascular Pre-Slit is a wound dressing manufactured from chitosan. When applied directly to the wound, the OneStop
20870053001033 - HemCon® Dental Dressing PRO, 10mm x 12mm2021-07-19 The HemCon Dental Dressing PRO is a chitosan-based oral wound dressing intended as a physical barrier for temporary protection o
20870053001118 - HemCon® Dental Dressing PRO, 1in x 3in2021-07-19 The HemCon Dental Dressing PRO is a chitosan-based oral wound dressing intended as a physical barrier for temporary protection o
00870053001268 - HemCon® Strip PRO, 1in x 4in2021-07-19 The HemCon® Strip PRO is a wound dressing manufactured from chitosan. When applied directly to the wound, the HemCon® Strip PR
00870053000117 - GuardaCare®XR Surgical, 4in x 4in, 8ply2021-07-16 HemCon GuardaCareXR Surgical is a hemostatic temporary surgical dressing comprised of a chitosan coated polyester/rayon blend, n
20870053000333 - HemCon® OneStop™ Bandage, 2in x 2in2021-05-13 The OneStop™ Bandage is a wound dressing manufactured from chitosan. When applied directly to the wound, the OneStop™ Bandag

Trademark Results [HemCon]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HEMCON
HEMCON
76268991 2735347 Live/Registered
TRICOL BIOMEDICAL, INC.
2001-06-07

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