ChitoGauzeXL, OTC, 3in x 4yd 1025

GUDID 50870053000303

ChitoGauze is intended for temporary external use to stop bleeding in minor wounds.

TRICOL BIOMEDICAL, INC.

Chitosan haemostatic agent, professional
Primary Device ID50870053000303
NIH Device Record Keyfdc251c2-5f7c-43d8-a8c8-c8ca5501dc76
Commercial Distribution StatusIn Commercial Distribution
Brand NameChitoGauzeXL, OTC, 3in x 4yd
Version Model Number1
Catalog Number1025
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 Perscriptionfalse
OTC Over-The-Countertrue

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100870053000308 [Primary]
GS150870053000303 [Package]
Contains: 00870053000308
Package: Case [50 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 Date2021-04-22
Device Publish Date2021-04-14

Devices Manufactured by TRICOL BIOMEDICAL, INC.

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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

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