ROEKO Calcium Hydroxide PLUS Points 366820

GUDID E1653668201

Coltène/Whaledent GmbH + Co. KG

Root canal obturating point
Primary Device IDE1653668201
NIH Device Record Keyb8f9c4e2-da9f-4658-a11d-27134fb05a41
Commercial Distribution StatusIn Commercial Distribution
Brand NameROEKO Calcium Hydroxide PLUS Points
Version Model NumberISO 20
Catalog Number366820
Company DUNS315494443
Company NameColtène/Whaledent GmbH + Co. KG
Device Count60
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4973458050
Emailinfo.de@coltene.com
Phone+4973458050
Emailinfo.de@coltene.com
Phone+4973458050
Emailinfo.de@coltene.com
Phone+4973458050
Emailinfo.de@coltene.com
Phone+4973458050
Emailinfo.de@coltene.com
Phone+4973458050
Emailinfo.de@coltene.com
Phone+4973458050
Emailinfo.de@coltene.com
Phone+4973458050
Emailinfo.de@coltene.com
Phone+4973458050
Emailinfo.de@coltene.com
Phone+4973458050
Emailinfo.de@coltene.com
Phone+4973458050
Emailinfo.de@coltene.com
Phone+4973458050
Emailinfo.de@coltene.com
Phone+4973458050
Emailinfo.de@coltene.com
Phone+4973458050
Emailinfo.de@coltene.com
Phone+4973458050
Emailinfo.de@coltene.com
Phone+4973458050
Emailinfo.de@coltene.com
Phone+4973458050
Emailinfo.de@coltene.com

Device Dimensions

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Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE1653668200 [Unit of Use]
HIBCCE1653668201 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EJKLiner, Cavity, Calcium Hydroxide

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-12-17
Device Publish Date2018-02-01

On-Brand Devices [ROEKO Calcium Hydroxide PLUS Points]

E16555330SAMPLE
E1653668970ASSORTMENT ISO 45-80
E1653668960ASSORTMENT ISO 15-40
E1653668801ISO 80
E1653668701ISO 70
E1653668601ISO 60
E1653668551ISO 55
E1653668501ISO 50
E1653668451ISO 45
E1653668401ISO 40
E1653668351ISO 35
E1653668301ISO 30
E1653668251ISO 25
E1653668201ISO 20
E1653668151ISO 15

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