EdgeDam™ Refill Heavy 6x6 Latex-Free EDVLFH6650

GUDID 00359883006709

Premium Polyisoprene Dental Dam

DEN-MAT HOLDINGS, LLC

Rubber dam, non-latex
Primary Device ID00359883006709
NIH Device Record Key832acf1f-70dd-434f-8e9b-0ec4ee02cafa
Commercial Distribution StatusIn Commercial Distribution
Brand NameEdgeDam™ Refill Heavy 6x6 Latex-Free
Version Model Number838203-E
Catalog NumberEDVLFH6650
Company DUNS809857704
Company NameDEN-MAT HOLDINGS, LLC
Device Count1
DM Exempttrue
Pre-market Exempttrue
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 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

Area/Surface Area36 Square inch
Area/Surface Area36 Square inch
Area/Surface Area36 Square inch
Area/Surface Area36 Square inch
Area/Surface Area36 Square inch
Area/Surface Area36 Square inch
Area/Surface Area36 Square inch
Area/Surface Area36 Square inch
Area/Surface Area36 Square inch
Area/Surface Area36 Square inch
Area/Surface Area36 Square inch
Area/Surface Area36 Square inch
Area/Surface Area36 Square inch
Area/Surface Area36 Square inch
Area/Surface Area36 Square inch
Area/Surface Area36 Square inch
Area/Surface Area36 Square inch

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100359883006709 [Primary]

FDA Product Code

EIEDAM, RUBBER

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-20
Device Publish Date2025-03-12

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