MicroMega Paper Points 60031749

GUDID E165600317490

MicroMega One RECI Paper Points 0.04 # 45

Coltène/Whaledent GmbH + Co. KG

Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point
Primary Device IDE165600317490
NIH Device Record Keye9052286-0664-4554-b5d9-b8d33a08308c
Commercial Distribution StatusIn Commercial Distribution
Brand NameMicroMega Paper Points
Version Model Number60031749
Catalog Number60031749
Company DUNS315494443
Company NameColtène/Whaledent GmbH + Co. KG
Device Count144
DM Exemptfalse
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 Datetrue
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
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE165600317490 [Unit of Use]
HIBCCE165600317492 [Primary]

FDA Product Code

EKNPoint, Paper, Endodontic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-02
Device Publish Date2024-03-25

On-Brand Devices [MicroMega Paper Points]

E165600317500MicroMega One RECI Paper Points 0.06 # 25
E165600317490MicroMega One RECI Paper Points 0.04 # 45
E165600317480MicroMega One RECI Paper Points 0.04 # 35
E165600317470MicroMega One RECI Paper Points 0.04 # 25
E165600317460MicroMega One RECI Paper Points 0.04 # 20

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