ChitoGauzeXR PRO, 3in x 4yds 1020

GUDID 20870053000562

HemCon ChitoGauzeXR PRO is a hemostatic dressing for the external, temporary control of severely bleeding wounds.

TRICOL BIOMEDICAL, INC.

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Primary Device ID20870053000562
NIH Device Record Key569d3368-bcf1-4fbd-a864-fd8c7c6b39e4
Commercial Distribution StatusIn Commercial Distribution
Brand NameChitoGauzeXR PRO, 3in x 4yds
Version Model Number1
Catalog Number1020
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
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
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
GS100870053000568 [Primary]
GS120870053000562 [Package]
Contains: 00870053000568
Package: Box [10 Units]
In Commercial Distribution
GS150870053000563 [Package]
Package: Case [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QSYHemostatic Wound Dressing Without Thrombin Or Other Biologics

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-07
Device Publish Date2024-05-30

Devices Manufactured by TRICOL BIOMEDICAL, INC.

20870053000562 - ChitoGauzeXR PRO, 3in x 4yds2024-06-07HemCon ChitoGauzeXR PRO is a hemostatic dressing for the external, temporary control of severely bleeding wounds.
20870053000562 - ChitoGauzeXR PRO, 3in x 4yds2024-06-07 HemCon ChitoGauzeXR PRO is a hemostatic dressing for the external, temporary control of severely bleeding wounds.
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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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