Tissue Goo™ Hemostatic Gel 4-Pack 641904

GUDID 00359883005665

Gingival Retraction Solution

DEN-MAT HOLDINGS, LLC

Gingival retraction solution
Primary Device ID00359883005665
NIH Device Record Keya0bc15b7-5bcd-47db-9dd4-835a59286e2f
Commercial Distribution StatusIn Commercial Distribution
Brand NameTissue Goo™ Hemostatic Gel 4-Pack
Version Model Number641904
Catalog Number641904
Company DUNS809857704
Company NameDEN-MAT HOLDINGS, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com

Device Dimensions

Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Store in cool, well-ventilated area.
Handling Environment TemperatureBetween 18 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Store in cool, well-ventilated area.
Handling Environment TemperatureBetween 18 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Store in cool, well-ventilated area.
Handling Environment TemperatureBetween 18 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Store in cool, well-ventilated area.
Handling Environment TemperatureBetween 18 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Store in cool, well-ventilated area.
Handling Environment TemperatureBetween 18 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Store in cool, well-ventilated area.
Handling Environment TemperatureBetween 18 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Store in cool, well-ventilated area.
Handling Environment TemperatureBetween 18 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Store in cool, well-ventilated area.
Handling Environment TemperatureBetween 18 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Store in cool, well-ventilated area.
Handling Environment TemperatureBetween 18 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Store in cool, well-ventilated area.
Handling Environment TemperatureBetween 18 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Store in cool, well-ventilated area.
Handling Environment TemperatureBetween 18 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Store in cool, well-ventilated area.
Handling Environment TemperatureBetween 18 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Store in cool, well-ventilated area.
Handling Environment TemperatureBetween 18 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Store in cool, well-ventilated area.
Handling Environment TemperatureBetween 18 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Store in cool, well-ventilated area.
Handling Environment TemperatureBetween 18 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Store in cool, well-ventilated area.
Handling Environment TemperatureBetween 18 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Store in cool, well-ventilated area.
Handling Environment TemperatureBetween 18 Degrees Celsius and 24 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100359883005665 [Primary]

FDA Product Code

MVLCORD, RETRACTION

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-26
Device Publish Date2025-03-18

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Trademark Results [Tissue Goo]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TISSUE GOO
TISSUE GOO
76575183 2999897 Live/Registered
Clinician's Choice Dental Products, Inc.
2004-02-10

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