First String Advanced Braided Retraction Cord Non-Impregnated - Small 640108

GUDID 00359883005634

Gingival retraction cord, non-medicated

DEN-MAT HOLDINGS, LLC

Gingival retraction cord, non-medicated
Primary Device ID00359883005634
NIH Device Record Keyf3f240f7-9864-49ab-b5ef-20789acad050
Commercial Distribution StatusIn Commercial Distribution
Brand NameFirst String Advanced Braided Retraction Cord Non-Impregnated - Small
Version Model Number640108
Catalog Number640108
Company DUNS809857704
Company NameDEN-MAT HOLDINGS, LLC
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
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

Length244 Centimeter
Length244 Centimeter
Length244 Centimeter
Length244 Centimeter
Length244 Centimeter
Length244 Centimeter
Length244 Centimeter
Length244 Centimeter
Length244 Centimeter
Length244 Centimeter
Length244 Centimeter
Length244 Centimeter
Length244 Centimeter
Length244 Centimeter
Length244 Centimeter
Length244 Centimeter
Length244 Centimeter

Operating and Storage Conditions

Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat, sparks and flame.
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat, sparks and flame.
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat, sparks and flame.
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat, sparks and flame.
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat, sparks and flame.
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat, sparks and flame.
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat, sparks and flame.
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat, sparks and flame.
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat, sparks and flame.
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat, sparks and flame.
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat, sparks and flame.
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat, sparks and flame.
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat, sparks and flame.
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat, sparks and flame.
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat, sparks and flame.
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat, sparks and flame.
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat, sparks and flame.

Device Identifiers

Device Issuing AgencyDevice ID
GS100359883005634 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2025-03-20
Device Publish Date2025-03-12

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