HyFlex Paper Points 60036503

GUDID 04260614073418

HyFlex™ EDM OGSF Paper Points 0.04 # 30

Coltène/Whaledent GmbH + Co. KG

Endodontic paper point
Primary Device ID04260614073418
NIH Device Record Key4714318d-90dd-42cc-b363-f4127f6cbb99
Commercial Distribution StatusIn Commercial Distribution
Brand NameHyFlex Paper Points
Version Model Number60036503
Catalog Number60036503
Company DUNS315494443
Company NameColtène/Whaledent GmbH + Co. KG
Device Count100
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 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
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

Device Identifiers

Device Issuing AgencyDevice ID
GS104260614073418 [Unit of Use]
GS114260614073415 [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

Devices Manufactured by Coltène/Whaledent GmbH + Co. KG

E165H021220 - HYGENIC® Paper Points2025-02-11 HYGENIC® Absorbent Paper Points ISO 60
E165H021230 - HYGENIC® Paper Points2025-02-11 HYGENIC® Absorbent Paper Points ISO 70
E165H021240 - HYGENIC® Paper Points2025-02-11 HYGENIC® Absorbent Paper Points ISO 80
E165H021300 - HYGENIC® Paper Points2025-02-11 HYGENIC® Absorbent Paper Points ISO 15 - 40
E165H021310 - HYGENIC® Paper Points2025-02-11 HYGENIC® Absorbent Paper Points ISO 45 - 80
E165H031870 - HYGENIC® Paper Points2025-02-11 HYGENIC® STER-I-CELL Paper Points Top color ISO 50
E165H031880 - HYGENIC® Paper Points2025-02-11 HYGENIC® STER-I-CELL Paper Points Top color ISO 55
E165H031890 - HYGENIC® Paper Points2025-02-11 HYGENIC® STER-I-CELL Paper Points Top color ISO 60

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