remanium®

GUDID J011765113000

Standard-Arches Lower 0,40mm

DENTAURUM GmbH & Co.KG

Orthodontic archwire
Primary Device IDJ011765113000
NIH Device Record Key960c5696-f9cb-4e6f-96a0-528f0ea5da75
Commercial Distribution Discontinuation2024-06-19
Commercial Distribution StatusNot in Commercial Distribution
Brand Nameremanium®
Version Model Number765-113-00
Company DUNS315427286
Company NameDENTAURUM GmbH & Co.KG
Device Count100
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 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)523-3946
Emailinfo@dentaurum-us.com
Phone+1(800)523-3946
Emailinfo@dentaurum-us.com
Phone+1(800)523-3946
Emailinfo@dentaurum-us.com
Phone+1(800)523-3946
Emailinfo@dentaurum-us.com
Phone+1(800)523-3946
Emailinfo@dentaurum-us.com
Phone+1(800)523-3946
Emailinfo@dentaurum-us.com
Phone+1(800)523-3946
Emailinfo@dentaurum-us.com
Phone+1(800)523-3946
Emailinfo@dentaurum-us.com
Phone+1(800)523-3946
Emailinfo@dentaurum-us.com
Phone+1(800)523-3946
Emailinfo@dentaurum-us.com
Phone+1(800)523-3946
Emailinfo@dentaurum-us.com
Phone+1(800)523-3946
Emailinfo@dentaurum-us.com
Phone+1(800)523-3946
Emailinfo@dentaurum-us.com
Phone+1(800)523-3946
Emailinfo@dentaurum-us.com
Phone+1(800)523-3946
Emailinfo@dentaurum-us.com
Phone+1(800)523-3946
Emailinfo@dentaurum-us.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *No special storage conditions required
Special Storage Condition, SpecifyBetween 0 and 0 *No special storage conditions required
Special Storage Condition, SpecifyBetween 0 and 0 *No special storage conditions required
Special Storage Condition, SpecifyBetween 0 and 0 *No special storage conditions required
Special Storage Condition, SpecifyBetween 0 and 0 *No special storage conditions required
Special Storage Condition, SpecifyBetween 0 and 0 *No special storage conditions required
Special Storage Condition, SpecifyBetween 0 and 0 *No special storage conditions required
Special Storage Condition, SpecifyBetween 0 and 0 *No special storage conditions required
Special Storage Condition, SpecifyBetween 0 and 0 *No special storage conditions required
Special Storage Condition, SpecifyBetween 0 and 0 *No special storage conditions required
Special Storage Condition, SpecifyBetween 0 and 0 *No special storage conditions required
Special Storage Condition, SpecifyBetween 0 and 0 *No special storage conditions required
Special Storage Condition, SpecifyBetween 0 and 0 *No special storage conditions required
Special Storage Condition, SpecifyBetween 0 and 0 *No special storage conditions required
Special Storage Condition, SpecifyBetween 0 and 0 *No special storage conditions required
Special Storage Condition, SpecifyBetween 0 and 0 *No special storage conditions required

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCJ011765113000 [Primary]
HIBCCJ011765113001 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZCWIRE, ORTHODONTIC

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-06-19
Device Publish Date2016-09-15

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J011765113000Standard-Arches Lower 0,40mm

Trademark Results [remanium]

Mark Image

Registration | Serial
Company
Trademark
Application Date
REMANIUM
REMANIUM
79000810 3011516 Live/Registered
DENTAURUM GmbH & Co. KG
2004-01-03

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