HyFlex Guttapercha Points 60036504

GUDID 04260614073401

HyFlex EDM OGSF Guttapercha Points 0.04 # 30

Coltène/Whaledent GmbH + Co. KG

Root canal obturating point Root canal obturating point Root canal obturating point Root canal obturating point Root canal obturating point Root canal obturating point Root canal obturating point Root canal obturating point Root canal obturating point Root canal obturating point Root canal obturating point Root canal obturating point Root canal obturating point Root canal obturating point Root canal obturating point Root canal obturating point Root canal obturating point Root canal obturating point Root canal obturating point Root canal obturating point Root canal obturating point Root canal obturating point Root canal obturating point Root canal obturating point Root canal obturating point Root canal obturating point Root canal obturating point Root canal obturating point Root canal obturating point Root canal obturating point Root canal obturating point

Primary Device ID	04260614073401
NIH Device Record Key	8da5c157-aab8-4158-bf10-fca9c035e5d0
Commercial Distribution Status	In Commercial Distribution
Brand Name	HyFlex Guttapercha Points
Version Model Number	60036504
Catalog Number	60036504
Company DUNS	315494443
Company Name	Coltène/Whaledent GmbH + Co. KG
Device Count	60
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+4973458050
Email	service@coltene.com
Phone	+4973458050
Email	service@coltene.com
Phone	+4973458050
Email	service@coltene.com
Phone	+4973458050
Email	service@coltene.com
Phone	+4973458050
Email	service@coltene.com
Phone	+4973458050
Email	service@coltene.com
Phone	+4973458050
Email	service@coltene.com
Phone	+4973458050
Email	service@coltene.com
Phone	+4973458050
Email	service@coltene.com
Phone	+4973458050
Email	service@coltene.com
Phone	+4973458050
Email	service@coltene.com
Phone	+4973458050
Email	service@coltene.com
Phone	+4973458050
Email	service@coltene.com
Phone	+4973458050
Email	service@coltene.com
Phone	+4973458050
Email	service@coltene.com
Phone	+4973458050
Email	service@coltene.com
Phone	+4973458050
Email	service@coltene.com
Phone	+4973458050
Email	service@coltene.com
Phone	+4973458050
Email	service@coltene.com
Phone	+4973458050
Email	service@coltene.com
Phone	+4973458050
Email	service@coltene.com
Phone	+4973458050
Email	service@coltene.com
Phone	+4973458050
Email	service@coltene.com
Phone	+4973458050
Email	service@coltene.com
Phone	+4973458050
Email	service@coltene.com
Phone	+4973458050
Email	service@coltene.com
Phone	+4973458050
Email	service@coltene.com
Phone	+4973458050
Email	service@coltene.com
Phone	+4973458050
Email	service@coltene.com
Phone	+4973458050
Email	service@coltene.com
Phone	+4973458050
Email	service@coltene.com

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *keep dry
Special Storage Condition, Specify	Between 0 and 0 *keep away from sunlight
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *keep dry
Special Storage Condition, Specify	Between 0 and 0 *keep away from sunlight
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *keep dry
Special Storage Condition, Specify	Between 0 and 0 *keep away from sunlight
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *keep dry
Special Storage Condition, Specify	Between 0 and 0 *keep away from sunlight
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *keep dry
Special Storage Condition, Specify	Between 0 and 0 *keep away from sunlight
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *keep dry
Special Storage Condition, Specify	Between 0 and 0 *keep away from sunlight
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *keep dry
Special Storage Condition, Specify	Between 0 and 0 *keep away from sunlight
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *keep dry
Special Storage Condition, Specify	Between 0 and 0 *keep away from sunlight
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *keep dry
Special Storage Condition, Specify	Between 0 and 0 *keep away from sunlight
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *keep dry
Special Storage Condition, Specify	Between 0 and 0 *keep away from sunlight
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *keep dry
Special Storage Condition, Specify	Between 0 and 0 *keep away from sunlight
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *keep dry
Special Storage Condition, Specify	Between 0 and 0 *keep away from sunlight
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *keep dry
Special Storage Condition, Specify	Between 0 and 0 *keep away from sunlight
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *keep dry
Special Storage Condition, Specify	Between 0 and 0 *keep away from sunlight
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *keep dry
Special Storage Condition, Specify	Between 0 and 0 *keep away from sunlight
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *keep dry
Special Storage Condition, Specify	Between 0 and 0 *keep away from sunlight
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *keep dry
Special Storage Condition, Specify	Between 0 and 0 *keep away from sunlight
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *keep dry
Special Storage Condition, Specify	Between 0 and 0 *keep away from sunlight
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *keep dry
Special Storage Condition, Specify	Between 0 and 0 *keep away from sunlight
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *keep dry
Special Storage Condition, Specify	Between 0 and 0 *keep away from sunlight
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *keep dry
Special Storage Condition, Specify	Between 0 and 0 *keep away from sunlight
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *keep dry
Special Storage Condition, Specify	Between 0 and 0 *keep away from sunlight
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *keep dry
Special Storage Condition, Specify	Between 0 and 0 *keep away from sunlight
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *keep dry
Special Storage Condition, Specify	Between 0 and 0 *keep away from sunlight
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *keep dry
Special Storage Condition, Specify	Between 0 and 0 *keep away from sunlight
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *keep dry
Special Storage Condition, Specify	Between 0 and 0 *keep away from sunlight
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *keep dry
Special Storage Condition, Specify	Between 0 and 0 *keep away from sunlight
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *keep dry
Special Storage Condition, Specify	Between 0 and 0 *keep away from sunlight
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *keep dry
Special Storage Condition, Specify	Between 0 and 0 *keep away from sunlight
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *keep dry
Special Storage Condition, Specify	Between 0 and 0 *keep away from sunlight
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *keep dry
Special Storage Condition, Specify	Between 0 and 0 *keep away from sunlight
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260614073401 [Unit of Use]
GS1	14260614073408 [Primary]

FDA Product Code

EKM	Gutta-Percha

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2024-04-02
Device Publish Date	2024-03-25

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